Identity
- Trade Name
- MemoFix® Super Elastic Nitinol Staple System FDA UDI
- Generic Name
- Surgical instrument/implant depth limiter, reusable FDA UDI
- Device Name
- Integra® MemoFix® Staple System The MemoFix drill stop adapter is used for precise drilling depth. FDA UDI
- Model / Reference
- MS-2714 FDA UDI
- Description
- Integra® MemoFix® Staple System The MemoFix drill stop adapter is used for precise drilling depth. FDA UDI
Identifiers
- Catalog Number
- MS-2714 FDA UDI
- Primary DI / UDI-DI
- 10381780246152 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical instrument/implant depth limiter, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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: Surgical instrument/implant depth limiter, reusable
MemoFix® Super Elastic Nitinol Staple System by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/implant depth limiter, reusable.
- Drill Stop — Oco Biomedical · Class I
- NOBEL SELECT MARKING PIN LONG 3.6mm X 27mm — W.H. Holden, Inc. · Class I
- Leith Medical Plating System Instruments — Leith Medical LLC · Class II
- EV ASTRA PIN - EV 1.9mm X 24mm — W.H. Holden, Inc. · Class I
- MemoFix Super Elastic Nitinol Staple System — Smith & Nephew, Inc. · Class I
- Drill Stop for Pilot Drill — Oco Biomedical · Class I
- MAS PLIF — Nuvasive, Inc. · Class I
- AXIOM® — ETABLISSEMENTS ANTHOGYR · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 05df5699-f331-4ae9-85d2-6c07dc9faf84 37 fields · synced Jun 7, 2026