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398.52

by Synthes GmbH

398.52 (39852) is a Class I device made by Synthes GmbH, listed in FDA GUDID since 31 Dec 2016 (UDI-DI 10886982201416), registry data as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982201416 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  • Withdrawn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 hook
Model / Ref / Catalog
398.52, 39852
Primary DI / UDI-DI
10886982201416
FDA product code
KIK
GMDN term
Bone hook
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Bone hook.

Other devices from Synthes GmbH

  • Tomofix

    Class IIb
  • 03.111.100S

    Class IIb
  • 68.134.011

    Class II
  • Volt 68.134.111

    Class II

See all devices from Synthes GmbH →

Properties

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