Identity
- Trade Name
- PRIMA Proximal Femur Locking Plate System FDA UDI
- Generic Name
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- 4.5mm Proximal Femur Plate, 140°, 4 hole, 18° flare, no offset, SS FDA UDI
- Model / Reference
- 11-114-441800S-1 FDA UDI
- Description
- 4.5mm Proximal Femur Plate, 140°, 4 hole, 18° flare, no offset, SS FDA UDI
Identifiers
- Primary DI / UDI-DI
- B56211113441800S10 FDA UDI
- 510(k) Number
- K230527 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
PRIMA Proximal Femur Locking Plate System by Wishbone Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial.
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- DVR® CROSSLOCKDISTAL VOLAR RADIUS PLATE MEDIUM RIGHT — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K230527 also covers:
- PRIMA Distal Femur Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Distal Femur Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Distal Femur Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Distal Femur Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Distal Femur Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Distal Femur Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Distal Femur Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Femoral Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Femoral Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Femoral Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Femoral Locking Plate System — WISHBONE MEDICAL INC.
- PRIMA Femoral Locking Plate System — WISHBONE MEDICAL INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Wishbone Medical Inc.
Sources (1)
- FDA UDI f5d9d38b-1b52-493c-a470-d6d3b6864cca 35 fields · synced May 30, 2026