Identity
- Trade Name
- WishFIX FDA UDI
- Generic Name
- Growth-correction orthopaedic fixation plate kit FDA UDI
- Device Name
- Procedure Kit, Curved 4-Hole X 16mm WishFIX Plate, Instruments and Screws, SS FDA UDI
- Model / Reference
- PK-EFC0416S-08 FDA UDI
- Description
- Procedure Kit, Curved 4-Hole X 16mm WishFIX Plate, Instruments and Screws, SS FDA UDI
Identifiers
- Primary DI / UDI-DI
- B562PKEFC0416S080 FDA UDI
- 510(k) Number
- K182704 FDA UDI
- FDA Product Code
- OBT FDA UDI
- GMDN Term
- Growth-correction orthopaedic fixation plate kit 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
Yes
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: Growth-correction orthopaedic fixation plate kit
WishFIX by Wishbone Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Growth-correction orthopaedic fixation plate kit.
- PROVIEW — Orthofix US LLC · Class I
- Locking Cannulated Blade Plate — ORTHOPEDIATRICS CORP. · Class II
- Locking Cannulated Blade Plate System — ORTHOPEDIATRICS CORP. · Class II
- Locking Cannulated Blade Plate System — ORTHOPEDIATRICS CORP. · Class II
- PROVIEW — Orthofix US LLC · Class I
- NAVIGATED INSTRUMENTS;PHOENIX SFS — Orthofix US LLC · Class II
- SCFE Screw — ORTHOPEDIATRICS CORP. · Class II
- PROVIEW — Orthofix US LLC · Class I
Cleared under the same submission
K182704 also covers:
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — WISHBONE MEDICAL INC.
- WishFIX — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wishbone Medical Inc.
Sources (1)
- FDA UDI 00529442-8a03-438d-9e07-e6fe7626f6a4 35 fields · synced Jun 8, 2026