Identity
- Trade Name
- Reign Medical FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- Clench Staple System, 11mm x 10mm FDA UDI
- Model / Reference
- 152-31110 FDA UDI
- Description
- Clench Staple System, 11mm x 10mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854325007028 FDA UDI
- 510(k) Number
- K173775 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Reign Medical by F & A Foundation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable.
- MotoCLIP/HiMAX Step Staple — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Step Boss — Biomedical Enterprises, Inc. · Class II
- Speed — Biomedical Enterprises, Inc. · Class II
- Elite — Synthes · Class II
- MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Speed Arc — Synthes · Class II
- JAWS Nitinol Staple System — Paragon 28 · Class II
Cleared under the same submission
K173775 also covers:
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
- Reign Medical — F & A FOUNDATION
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
- F & A Foundation
Sources (1)
- FDA UDI e99a563a-5677-4ca1-b34a-392503e19cc0 34 fields · synced May 30, 2026