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Zavation 989-1011-65

by Zavation

Zavation 989-1011-65 is a Class II device made by Zavation, cleared under FDA 510(k) K222614 on 5 Dec 2022 and listed in FDA GUDID since 3 Jan 2024 (UDI-DI 00197157009762), 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) K222614

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 Number00197157009762 UDI-DI Date3 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222614 Date5 Dec 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222614 decided 5 Dec 2022 Active
  • FDA GUDID UDI-DI 00197157009762 listed 3 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222614
  2. Listed FDA GUDID 00197157009762

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Zavation
Generic name
Bone tap, reusable
Model / reference
989-1011-65
Primary DI / UDI-DI
00197157009762
510(k) Number
FDA product code
NKB, KWQ
GMDN term
Bone tap, reusable
Device class
Class II
Regulation number
888.3070, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone tap, reusable

Cleared under the same submission (K222614)

and 8 more cleared under K222614

Other devices from Zavation

See all devices from Zavation →

Properties

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