Identity
- Trade Name
- 5/6 X 275MM CENTRALLY THREADED PIN FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 5 ID / 6 OD X 275MM CENTRALLY THREADED PIN FDA UDI
- Model / Reference
- 303-50275 FDA UDI
- Description
- 5 ID / 6 OD X 275MM CENTRALLY THREADED PIN FDA UDI
Identifiers
- Catalog Number
- 303-50275 FDA UDI
- Primary DI / UDI-DI
- 00816950029660 FDA UDI
- 510(k) Number
- K160603 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6 Millimeter FDA UDILength — 275 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
A comprehensive medical device directory entry for the 5/6 X 275MM Centrally Threaed Pin, an orthopaedic bone screw (non-sliding) designed for internal fixation of limb bones, ribs, sternum, and pelvis. This device is intended for intramedullary stabilization of fractures and provides direct interfragmentary support.
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K160603 also covers:
- 3.2 X 125MM DRILL BIT NO SIDE CUTTING — OsteoCentric Technologies,Inc
- 4.0 X 105MM SCHANZ PIN FASTENER 45MM THD — OsteoCentric Technologies,Inc
- 4.0 X 125MM TAP — OsteoCentric Technologies,Inc
- 4.0 X 150MM SCHANZ PIN FASTENER 55MM THD — OsteoCentric Technologies,Inc
- 4.0 X 235MM DRILL BIT NO SIDE CUTTING — OsteoCentric Technologies,Inc
- 4.0 X 30MM DRILL SLEEVE — OsteoCentric Technologies,Inc
- 4.0 X 30MM OUTER SLEEVE — OsteoCentric Technologies,Inc
- 4.0 X 30MM TROCAR — OsteoCentric Technologies,Inc
- 4.0 X 95MM SCHANZ PIN FASTENER 35MM THD — OsteoCentric Technologies,Inc
- 4.5 X 235MM DRILL BIT NO SIDE CUTTING — OsteoCentric Technologies,Inc
- 5.0 X 120MM DRILL SLEEVE — OsteoCentric Technologies,Inc
- 5.0 X 120MM OUTER SLEEVE — OsteoCentric Technologies,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
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI fae57e1b-deb5-41a3-a23d-5f02a0fefc05 37 fields · synced Jun 29, 2026