Atlas FDA

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

FDA 510(k) clearance K111667 · decided 2011-12-05

Clearance details

K-number
K111667
Device name
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
Applicant
Synthes (Usa)
Decision
Substantially Equivalent
Date received
2011-06-14
Decision date
2011-12-05
Days to decision
174 days
Clearance type
Special
Product code
JDS
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
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection recall (Z-0404-2014)Synthes (USA) Products LLC2013-11-26

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