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Zavation 150-0230

by Zavation

Zavation 150-0230 is a Class II device made by Zavation, cleared under FDA 510(k) K130030 on 25 Apr 2013 and listed in FDA GUDID since 10 Nov 2017 (UDI-DI 00842166109209), 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) K130030

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 Number00842166109209 UDI-DI Date10 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130030 Date25 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130030 decided 25 Apr 2013 Active
  • FDA GUDID UDI-DI 00842166109209 listed 10 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130030
  2. Listed FDA GUDID 00842166109209

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  • Withdrawn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
Spinal fixation plate, non-bioabsorbable
Model / reference
150-0230
Primary DI / UDI-DI
00842166109209
510(k) Number
FDA product code
KWQ
GMDN term
Spinal fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Spinal fixation plate, non-bioabsorbable.

Other devices from Zavation

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Properties

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