Identity
- Trade Name
- Nitinex Memory Staple FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable, non-sterile FDA UDI
- Device Name
- Staple, Nitinex 20x16x16mm FDA UDI
- Model / Reference
- ST-201616 FDA UDI
- Description
- Staple, Nitinex 20x16x16mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731106797 FDA UDI
- 510(k) Number
- K112837 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable, non-sterile 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Category: Orthopaedic bone staple, non-adjustable, non-sterile
Nitinex Memory Staple by Vilex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable, non-sterile.
- 20mm x 20mm x 20mm Staple — Trilliant Surgical LLC · Class II
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- Orbitum VI Staple — CPM Medical Consultants, LLC · Class II
- 18mm x 15mm x 15mm Staple — Trilliant Surgical LLC · Class II
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- Orbitum VI Staple — CPM Medical Consultants, LLC · Class II
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- VARISATION STAPLEØ 1, 0MM — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K112837 also covers:
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, Inc.
- Nitinex Memory Staple — Vilex, 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
- Vilex, Inc.
Sources (1)
- FDA UDI beee7e61-090c-4644-9a63-8acc5b5f7239 34 fields · synced May 30, 2026