ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR— 510(k) K932595

Name: FDA 510(k) clearance K932595
Creator: U.S. Food and Drug Administration
Published: 1994-09-20

Substantially Equivalent

Johnson & Johnson Orthopaedics, Inc.

FDA 510(k) clearance K932595 for ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR, Substantially Equivalent on 1994-09-20. Applicant: Johnson & Johnson Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Johnson & Johnson Orthopaedics, Inc.
Product code: Code LZN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1993-05-28
Decision date: 1994-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZN

view all

K220838 — Artisan Bone Plug, Universal Cement Restrictor2022-05-20
K061824 — TORNIER CEMENT RESTRICTOR2006-09-14
K032685 — CEMSTOP CEMENT RESTRICTOR2003-11-26
K023680 — BIOBUCK CEMENT RESTRICTOR2002-11-19
K011943 — IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR2001-09-19

More clearances from Johnson & Johnson Orthopaedics, Inc.

view all

K931466 — PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI1994-12-06
K935452 — P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT1994-10-06
K940190 — ULTIMA UNIPOLAR MODULAR HEAD1994-09-29
K933275 — P.F.C. CERAMIC HIP HEAD1994-09-28
K931655 — P.F.C. BIPOLAR HIP SYSTEM1994-06-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.