Sulzer Orthopedics Converge Acetabular System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K012961 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Natural-Hip Cocr Offset Stem

  Class II

  FDA 510(k) K973681 Active Cleared 19 Dec 1997

• Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

  Class II

  FDA 510(k) K983153 Active Cleared 4 Dec 1998

• Natural-Hip Porous Stem with Offset

  Class II

  FDA 510(k) K973675 Active Cleared 19 Dec 1997

• Allofit Acetabular System 32mm Alpha Durasul Inserts

  Class II

  FDA 510(k) K013935 Active Cleared 13 Dec 2001

• Magna-Rom 21 Knee Systeem

  Class II

  FDA 510(k) K991143 Active Cleared 11 Jun 1999

• Unicondylar Interpositional Spacer

  Class II

  FDA 510(k) K003269 Active Cleared 4 Jan 2001

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