Atlas FDA

SYNTHES (USA) MODULAR BLADE PLATE SYSTEM

FDA 510(k) clearance K080109 · decided 2008-03-20

Clearance details

K-number
K080109
Device name
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
Applicant
Synthes (Usa)
Decision
Substantially Equivalent
Date received
2008-01-15
Decision date
2008-03-20
Days to decision
65 days
Clearance type
Traditional
Product code
KTW
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
West Chester, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
02.122.550, 50mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1261-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.550S, 50mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1262-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.551, 50mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1263-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.551S, 50mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1264-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1265-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1266-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.556, 55mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1267-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1268-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.561, 60mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1269-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1270-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1271-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.565S, 65mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1272-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.566, 65mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1273-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.566S, 65mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1274-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.570, 70mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1275-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.570S, 70mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1276-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.571, 70mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1277-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.571S, 70mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1278-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.575, 75mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1279-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.575S, 75mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1280-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.576, 75mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1281-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.576S, 75mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1282-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.580, 80mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1283-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.580S, 80mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1284-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.581, 80mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1285-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.581S, 80mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1286-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.585S, 85mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1288-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.586, 85mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1289-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1290-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1292-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.591, 90mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1293-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1294-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.595, 95mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes recall (Z-1295-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of th recall (Z-1296-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.596, 95mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1297-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.596S, 95mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the recall (Z-1298-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.600, 100mm Spiral Blade, 14mm, Right- Synthes Spiral Blade Component of the Synthes recall (Z-1299-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.601, 100mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1301-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.601S, 100mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of th recall (Z-1302-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.605, 105mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthe recall (Z-1303-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of t recall (Z-1304-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.606, 105mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1305-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.606S, 105mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of th recall (Z-1306-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.610, 110mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthe recall (Z-1307-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of t recall (Z-1308-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.611, 110mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1309-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.611S, 110mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of th recall (Z-1310-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthe recall (Z-1311-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.615S, 115mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of t recall (Z-1312-2011)Synthes USA (HQ), Inc.2011-02-16
02.122.616, 115mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes recall (Z-1313-2011)Synthes USA (HQ), Inc.2011-02-16

PMA approvals by this applicant

RecordFirmDate
NORIAN SRS BONE CEMENT (P970010/S004)Synthes (Usa)2000-08-31
NORIAN SRS CEMENT (P970010/S002)Synthes (Usa)2000-04-28
NORIAN SRS CEMENT (P970010/S001)Synthes (Usa)1999-07-16
NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010)Synthes (Usa)1998-12-23