Identity
- Trade Name
- VARISATION STAPLE FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Model / Reference
- 1010-26-008 FDA UDI
Identifiers
- Catalog Number
- 101026008 FDA UDI
- Primary DI / UDI-DI
- 00887868010620 FDA UDI
- 510(k) Number
- K931155 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Varisation Staple by Biomet Orthopedics, Inc. — 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
K931155 also covers:
- VARISATION STAPLE — Biomet Orthopedics, Inc.
- VARISATION STAPLE — Biomet Orthopedics, Inc.
- VARISATION STAPLE — Biomet Orthopedics, Inc.
- VARISATION STAPLEØ 1, 0MM — Biomet Orthopedics, Inc.
- VARISATION STAPLEØ 1, 0MM — Biomet Orthopedics, Inc.
- VARISATION STAPLEØ 1, 0MM — Biomet Orthopedics, Inc.
- VARISATION STAPLEØ 1, 0MM — Biomet Orthopedics, 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 1d43dcbf-1b27-462c-88c3-5e171e364ce3 36 fields · synced May 30, 2026