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04.168.330S

by Synthes

04.168.330S (04168330S) is a Class II device made by Synthes, cleared under FDA 510(k) K172872 on 5 Mar 2018 and listed in FDA GUDID since 25 Apr 2018 (UDI-DI 10886982274823), 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) K172872

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 Number10886982274823 UDI-DI Date25 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172872 Date5 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172872 decided 5 Mar 2018 Active
  • FDA GUDID UDI-DI 10886982274823 listed 25 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172872
  2. Listed FDA GUDID 10886982274823

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Orthopaedic bone bolt
Model / Ref / Catalog
04.168.330S, 04168330S
Primary DI / UDI-DI
10886982274823
510(k) Number
FDA product code
KTT
GMDN term
Orthopaedic bone bolt
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Related devices

Category: Orthopaedic bone bolt

Cleared under the same submission (K172872)

and 8 more cleared under K172872

Other devices from Synthes

  • 68.134.011

    Class II

  • Volt 68.134.111

    Class II

  • Volt 68.134.200

    Class II

  • 68.045.017

    Class II

See all devices from Synthes →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)