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Integra® MemoFix®

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

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. The system includes instruments, made from titanium and stainless steel, to facilitate the placement of the implants. FDA UDI
Model / Reference
STAPLEIMP 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. The system includes instruments, made from titanium and stainless steel, to facilitate the placement of the implants. FDA UDI

Identifiers

Catalog Number
STAPLEIMP FDA UDI
Primary DI / UDI-DI
10381780074298 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Integra® MemoFix® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K123926 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 10133d7e-1afd-43fe-ba67-44fc3ad8aff9 37 fields · synced Jun 1, 2026