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Uniplate 189706010

by Depuy Spine, Inc.

Uniplate 189706010 is a Class II device made by Depuy Spine, Inc., cleared under FDA 510(k) K171439 on 20 Jul 2017 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705034180564), 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

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 NumberK171439 Date20 Jul 2017DecidedStatusActive
United StatesGUDID listing Number10705034180564 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171439 decided 20 Jul 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705034180564 listed 24 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K042544
  2. Listed FDA GUDID 10705034180564
  3. Cleared FDA 510(k) K171439

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Uniplate
Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
189706010
Primary DI / UDI-DI
10705034180564
510(k) Number
FDA product code
KWQ
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K042544)

and 8 more cleared under K042544

Cleared under the same submission (K171439)

and 8 more cleared under K171439

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

Other devices from Depuy Spine, Inc.

See all devices from Depuy Spine, Inc. →

Properties

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