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Summit Cemented Hip Prosthesis

by Depuy Orthopaedics, Inc.

510(k) K013352

Summit Cemented Hip Prosthesis is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K013352 on 17 Dec 2001, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013352 Date17 Dec 2001ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JDI
Device class
Class II
Regulation
21 CFR Part 888.3350
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

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