Atlas FDA

SYNTHES BUTTON PLATE

FDA 510(k) clearance K994364 · decided 2000-03-15

Clearance details

K-number
K994364
Device name
SYNTHES BUTTON PLATE
Applicant
Synthes (Usa)
Decision
Substantially Equivalent
Date received
1999-12-27
Decision date
2000-03-15
Days to decision
79 days
Clearance type
Traditional
Product code
MBI
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Paoli, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue recall (Z-2138-2016)Synthes (USA) Products LLC2016-07-07

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