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FDA 510(k)

ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR

K-Number: K932595 · 1994-09-20

ApplicantJohnson & Johnson Orthopaedics, Inc.
Decision Date1994-09-20
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K932595. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR?

ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Johnson & Johnson Orthopaedics, Inc.. The 510(k) number is K932595.

When did ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR receive FDA 510(k) clearance?

ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR received FDA 510(k) clearance on 1994-09-20, under 510(k) number K932595.

Who is the listed applicant for ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR?

The FDA 510(k) record lists Johnson & Johnson Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR?

The FDA product code for ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR is LZN.

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Other records listing Johnson & Johnson Orthopaedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K931466PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRIK935452P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENTK940190ULTIMA UNIPOLAR MODULAR HEADK933275P.F.C. CERAMIC HIP HEADK931655P.F.C. BIPOLAR HIP SYSTEMK933867UNIVERSAL INSET PATELLA

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Related Devices (Code: LZN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker OrthopaedicsK061824TORNIER CEMENT RESTRICTORTornierK032685CEMSTOP CEMENT RESTRICTORTeknimed, S.A.K023680BIOBUCK CEMENT RESTRICTORSmith & Nephew, Inc.K011943IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTORKensey Nash Corp.K010840SYNPLUGIsotis NV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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