Atlas FDA

SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)

FDA 510(k) clearance K033669 · decided 2003-12-10

Clearance details

K-number
K033669
Device name
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2003-11-21
Decision date
2003-12-10
Days to decision
19 days
Clearance type
Special
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Cordova, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 718007 recall (Z-2314-2010)Smith & Nephew Inc2010-08-31

PMA approvals by this applicant

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Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
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BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10