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V-Tek™ 28.65.034

by Zimmer, Inc.

V-Tek™ 28.65.034 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K151708 on 2 Mar 2016 and listed in FDA GUDID since 30 Dec 2016 (UDI-DI 00889024110205), 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) K151708

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 Number00889024110205 UDI-DI Date30 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151708 Date2 Mar 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151708 decided 2 Mar 2016 Active
  • FDA GUDID UDI-DI 00889024110205 listed 30 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151708
  2. Listed FDA GUDID 00889024110205

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
V-Tek™
Generic name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Model / reference
28.65.034
Primary DI / UDI-DI
00889024110205
510(k) Number
FDA product code
HTN, HWC
GMDN term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 34 Millimeter
Outer Diameter — 3 Millimeter

Related devices

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K151708)

and 8 more cleared under K151708

Similar devices in this category

Other devices filed under Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

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