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Isola 500064000

by Depuy Spine, Inc.

Isola 500064000 is a Class II device made by Depuy Spine, Inc., cleared under FDA 510(k) K013441 on 16 Nov 2001 and listed in FDA GUDID since 19 Jul 2024 (UDI-DI 10705034226866), 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) K013441

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 Number10705034226866 UDI-DI Date19 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK013441 Date16 Nov 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013441 decided 16 Nov 2001 Active
  • FDA GUDID UDI-DI 10705034226866 listed 19 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013441
  2. Listed FDA GUDID 10705034226866

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Isola
Generic name
Implantable bone washer
Model / Ref / Catalog
500064000
Primary DI / UDI-DI
10705034226866
510(k) Number
FDA product code
KWP, MNI, MNH
GMDN term
Implantable bone washer
Device class
Class II
Regulation number
888.3050, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Implantable bone washer

Cleared under the same submission (K013441)

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)