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397.084

by Synthes

397.084 (397084) is a Class I device made by Synthes, listed in FDA GUDID since 31 Dec 2016 (UDI-DI 10705034778495), registry data as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705034778495 UDI-DI Date31 Dec 2016ListedStatusListed 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  • Withdrawn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
Bone distraction forceps
Model / Ref / Catalog
397.084, 397084
Primary DI / UDI-DI
10705034778495
FDA product code
LXH
GMDN term
Bone distraction forceps
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone distraction forceps

Similar devices in this category

Other devices filed under Bone distraction forceps.

Other devices from Synthes

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  • 68.045.017

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See all devices from Synthes →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)