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Duraloc 1220-36-456

by Depuy Orthopaedics, Inc.

Duraloc 1220-36-456 (122036456) is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K010171 on 6 Apr 2001 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295015703), 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) K010171

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 Number10603295015703 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010171 Date6 Apr 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010171 decided 6 Apr 2001 Active
  • FDA GUDID UDI-DI 10603295015703 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010171
  2. Listed FDA GUDID 10603295015703

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Duraloc
Generic name
Non-constrained polyethylene acetabular liner
Model / Ref / Catalog
1220-36-456, 122036456
Primary DI / UDI-DI
10603295015703
510(k) Number
FDA product code
LPH
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class II
Regulation number
888.3358
GUDID distribution status
In Commercial Distribution

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)