Identity
- Trade Name
- Orion Headless Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Headless Cannulated Screw Short-Thread Ø3.0mm-(L) 22mm FDA UDI
- Model / Reference
- HTR-04-300422 FDA UDI
- Description
- Headless Cannulated Screw Short-Thread Ø3.0mm-(L) 22mm FDA UDI
Identifiers
- Catalog Number
- HTR-04-300422 FDA UDI
- Primary DI / UDI-DI
- M695HTR043004220 FDA UDI
- 510(k) Number
- K133842 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
MR Conditional FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Orion Headless Screw by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
K133842 also covers:
- Cannulated Compression Headless Screw — Tyber Medical
- Cannulated Compression Headless Screw — Tyber Medical
- Cannulated Compression Headless Screw — Tyber Medical
- Headless Screw System — Tyber Medical
- Headless Screw System — Tyber Medical
- Headless Screw System — Tyber Medical
- Headless Screw System — Tyber Medical
- Tyber Medical — Tyber Medical
- Tyber Medical — Tyber Medical
- Tyber Medical — Tyber Medical
- Tyber Medical — Tyber Medical
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
- Tyber Medical
Sources (1)
- FDA UDI 3da233fc-29ed-42c6-b8c8-f0631c2233e6 36 fields · synced Jun 6, 2026