Identity
- Trade Name
- WishBone Plate & Screw System FDA UDI
- Generic Name
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- Procedure Kit- 2.7 mm Cortical Screws (10 mm-16 mm) and Instruments, Ti FDA UDI
- Model / Reference
- PK-TCX27SM-US FDA UDI
- Description
- Procedure Kit- 2.7 mm Cortical Screws (10 mm-16 mm) and Instruments, Ti FDA UDI
Identifiers
- Catalog Number
- PK-TCX27SM FDA UDI
- Primary DI / UDI-DI
- B562PKTCX27SMUS0 FDA UDI
- 510(k) Number
- K180736 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Category: Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
WishBone Plate & Screw 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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- Opteryx® — Innovasis, Inc. · Class II
- Opteryx® — Innovasis, Inc. · Class II
- Opteryx® — Innovasis, Inc. · Class II
- OsteoMed — Osteomed Corp. · Class II
- Opteryx® — Innovasis, Inc. · Class II
- DVR® CROSSLOCKDISTAL VOLAR RADIUS PLATE MEDIUM RIGHT — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K180736 also covers:
- 2.7mm x 12mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 12mm Ti Locking Screw — WISHBONE MEDICAL INC.
- 2.7mm x 14mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 14mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 16mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 18mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 18mm Ti Locking Screw — WISHBONE MEDICAL INC.
- 2.7mm x 18mm Ti Locking Screw — WISHBONE MEDICAL INC.
- 2.7mm x 20mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 22mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 22mm Ti Locking Screw — WISHBONE MEDICAL INC.
- 2.7mm x 24mm Ti Locking Screw — 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 5ee624ee-21ae-47d1-bee4-bba2bda3da2d 35 fields · synced May 30, 2026