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A07A

by Medtronic Sofamor Danek, Inc.

A07A is a Class I device made by Medtronic Sofamor Danek, Inc., listed in FDA GUDID since 3 Oct 2021 (UDI-DI 00643169097889), registry data as of 9 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169097889 UDI-DI Date3 Oct 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Noninvasive manual orthopaedic cement preparation kit, reusable
Model / reference
A07A
Primary DI / UDI-DI
00643169097889
FDA product code
JDZ
GMDN term
Noninvasive manual orthopaedic cement preparation kit, reusable
Device class
Class I
Regulation number
888.4210
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual orthopaedic cement mixer, reusable

Similar devices in this category

Other devices filed under Manual orthopaedic cement mixer, reusable.

Other devices from Medtronic Sofamor Danek, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)