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Integra® MemoFix® MS101010

by Ascension Orthopedics, Inc.

Integra® MemoFix® MS101010 is a Class II device made by Ascension Orthopedics, Inc., cleared under FDA 510(k) K123926 on 3 May 2013 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780121350), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K123926

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780121350 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123926 Date3 May 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123926 decided 3 May 2013 Active
  • FDA GUDID UDI-DI 10381780121350 listed 9 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123926
  2. Listed FDA GUDID 10381780121350

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Integra® MemoFix®
Generic name
Orthopaedic bone staple, non-adjustable
Model / Ref / Catalog
MS101010
Primary DI / UDI-DI
10381780121350
510(k) Number
FDA product code
JDR
GMDN term
Orthopaedic bone staple, non-adjustable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone staple, non-adjustable

Cleared under the same submission (K123926)

and 8 more cleared under K123926

Similar devices in this category

Other devices filed under Orthopaedic bone staple, non-adjustable.

Other devices from Ascension Orthopedics, Inc.

See all devices from Ascension Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)