Identity
- Trade Name
- Tornier HRS FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Assembly Screw FDA UDI
- Model / Reference
- ARS655119 FDA UDI
- Description
- Assembly Screw FDA UDI
Identifiers
- Catalog Number
- ARS655119 FDA UDI
- Primary DI / UDI-DI
- 00846832093311 FDA UDI
- 510(k) Number
- K181420 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDIPHX FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Tornier HRS by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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Cleared under the same submission
K181420 also covers:
- Aequalis Flex Revive — TORNIER, INC.
- Aequalis Flex Revive — TORNIER, INC.
- Aequalis Flex Revive — TORNIER, INC.
- Aequalis Flex Revive — TORNIER, INC.
- Aequalis Flex Revive — TORNIER, INC.
- Aequalis Flex Revive — TORNIER, INC.
- Aequalis Flex Revive — TORNIER, INC.
- Tornier HRS — TORNIER, INC.
- Tornier HRS — TORNIER, INC.
- Tornier HRS — TORNIER, INC.
- Tornier HRS — TORNIER, INC.
- Tornier HRS — TORNIER, 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
- Tornier, Inc.
Sources (1)
- FDA UDI 23e0da02-8d1e-4a52-93a2-ea20ca7ad241 37 fields · synced Jun 1, 2026