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04.045.885S

by Synthes

04.045.885S (04045885S) is a Class II device made by Synthes, cleared under FDA 510(k) K160167 on 26 Sep 2016 and listed in FDA GUDID since 16 Dec 2020 (UDI-DI 10886982296085), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K160167

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 Number10886982296085 UDI-DI Date16 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160167 Date26 Sep 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160167 decided 26 Sep 2016 Active
  • FDA GUDID UDI-DI 10886982296085 listed 16 Dec 2020 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1239-2024 FDA Class II initiated 24 Jan 2024
    • Ongoing Z-1240-2024 FDA Class II initiated 24 Jan 2024

    Products not sterilized, sterility cannot be confirmed

Timeline

4 dated events

  1. Cleared FDA 510(k) K160167
  2. Listed FDA GUDID 10886982296085
  3. Recall initiated FDA recalls Z-1239-2024
  4. Recall initiated FDA recalls Z-1240-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Bone nail implantable cap
Model / Ref / Catalog
04.045.885S, 04045885S
Primary DI / UDI-DI
10886982296085
510(k) Number
FDA product code
HSB
GMDN term
Bone nail implantable cap
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone nail end-cap

Cleared under the same submission (K160167)

and 8 more cleared under K160167

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
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)