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Zavation 212-5560

by Zavation

Zavation 212-5560 is a medical device (FDA Class II; FDA product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar) made by Zavation, cleared under FDA 510(k) K153404 on 21 Apr 2016 and listed in FDA GUDID since 24 Jan 2018 (UDI-DI 00842166113503), active as of 22 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 22 Oct 2026

Documents

510(k) K153404

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842166113503 UDI-DI Date24 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153404 Date21 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153404 decided 21 Apr 2016 Active
  • FDA GUDID UDI-DI 00842166113503 listed 24 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153404
  2. Listed FDA GUDID 00842166113503

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  • Withdrawn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
Orthopaedic bone screw (non-sliding)
Model / reference
212-5560
Primary DI / UDI-DI
00842166113503
510(k) Number
FDA product code
OVD
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K153404)

and 8 more cleared under K153404

Similar devices in this category

Other devices filed under Orthopaedic bone screw (non-sliding).

Other devices from Zavation

See all devices from Zavation →

Properties

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