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Agility 1555-05-030

by Depuy Orthopaedics, Inc.

Agility 1555-05-030 (155505030) is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K020541 on 20 May 2002 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295058618), 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) K020541

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 Number10603295058618 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020541 Date20 May 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020541 decided 20 May 2002 Active
  • FDA GUDID UDI-DI 10603295058618 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020541
  2. Listed FDA GUDID 10603295058618

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Agility
Generic name
Coated ankle talus prosthesis
Model / Ref / Catalog
1555-05-030, 155505030
Primary DI / UDI-DI
10603295058618
510(k) Number
FDA product code
HSN
GMDN term
Coated ankle talus prosthesis
Device class
Class II
Regulation number
888.3110
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated ankle talus prosthesis

Cleared under the same submission (K020541)

and 7 more cleared under K020541

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)