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Exeter 0939-0-106

by Howmedica Osteonics Corp.

Exeter 0939-0-106 is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K191414 on 28 Aug 2019 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 04546540167194), 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

2 ongoing

Recall on shared 510(k) K173499; other models may be affected

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191414 Date28 Aug 2019DecidedStatusActive
United StatesGUDID listing Number04546540167194 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191414 decided 28 Aug 2019 Active· +2 more in the status table
  • FDA GUDID UDI-DI 04546540167194 listed 24 Sep 2015 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0313-2022 FDA Class II initiated 15 Oct 2021 on shared 510(k) K173499

    XXX

    • Ongoing Z-0314-2022 FDA Class II initiated 15 Oct 2021 on shared 510(k) K173499

    There is a potential for the outer white Tyvek lid to debond from the sealed package.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K980843
  2. Listed FDA GUDID 04546540167194
  3. Cleared FDA 510(k) K173499
  4. Cleared FDA 510(k) K191414
  5. Recall initiated FDA recalls Z-0313-2022
  6. Recall initiated FDA recalls Z-0314-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Exeter
Generic name
Polymer orthopaedic cement restrictor, non-bioabsorbable
Model / Ref / Catalog
0939-0-106
Primary DI / UDI-DI
04546540167194
FDA product code
JDI, LZN
GMDN term
Polymer orthopaedic cement restrictor, non-bioabsorbable
Device class
Class II
Regulation number
888.3350, 878.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

Cleared under the same submission (K173499)

and 8 more cleared under K173499

Cleared under the same submission (K191414)

and 4 more cleared under K191414

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)