Identity
- Trade Name
- Integra® MemoFix® FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies. FDA UDI
- Model / Reference
- MS101513 FDA UDI
- Description
- The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies. FDA UDI
Identifiers
- Catalog Number
- MS101513 FDA UDI
- Primary DI / UDI-DI
- 10381780121367 FDA UDI
- 510(k) Number
- K123926 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Integra® MemoFix® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable.
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- 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
K123926 also covers:
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension Orthopedics, Inc.
- Integra® MemoFix® — Ascension 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 |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI a3907c3c-a0e9-443e-b5b6-dd6d6fa35995 38 fields · synced Jun 8, 2026