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02-029-11-2000

by Exactech, Inc.

02-029-11-2000 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K181794 on 28 Sep 2018 (2 earlier submissions) and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 10885862522986), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862522986 UDI-DI Date28 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK181794 Date28 Sep 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181794 decided 28 Sep 2018 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10885862522986 listed 28 Jul 2022 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0585-2024 FDA Class II initiated 21 Nov 2023

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

    • Ongoing Z-0023-2022 FDA Class II initiated 30 Aug 2021

    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

Timeline

6 dated events

  1. Cleared FDA 510(k) K170240
  2. Cleared FDA 510(k) K171045
  3. Cleared FDA 510(k) K181794
  4. Recall initiated FDA recalls Z-0023-2022
  5. Listed FDA GUDID 10885862522986
  6. Recall initiated FDA recalls Z-0585-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
02-029-11-2000
Primary DI / UDI-DI
10885862522986
510(k) Number
FDA product code
MBH, JWH
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
888.3565, 888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K170240)

and 8 more cleared under K170240

Cleared under the same submission (K171045)

and 8 more cleared under K171045

Similar devices in this category

Other devices filed under Orthopaedic prosthesis implantation positioning instrument, reusable.

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)