Identity
- Trade Name
- Ulna Shortening Plating System FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Model / Reference
- K-Wire, Single Diamond, 1.6mm x 127mm FDA UDI
Identifiers
- Catalog Number
- KWIR-SD-16127 FDA UDI
- Primary DI / UDI-DI
- 00841506116204 FDA UDI
- 510(k) Number
- K201962 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
Ulna Shortening Plating System by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic intraoperative positioning pin, single-use.
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Cleared under the same submission
K201962 also covers:
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
- Ulna Shortening Plating System — SKELETAL DYNAMICS L.L.C.
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
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 0b8963ea-58cc-4649-ad9e-23be5838e1a5 35 fields · synced May 31, 2026