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FDA 510(k)

PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD

K-Number: K921836 · 1992-11-06

ApplicantOrthomet, Inc.
Decision Date1992-11-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1992-11-06 under 510(k) number K921836. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD?

PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Orthomet, Inc.. The 510(k) number is K921836.

When did PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD receive FDA 510(k) clearance?

PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD received FDA 510(k) clearance on 1992-11-06, under 510(k) number K921836.

Who is the listed applicant for PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD?

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

What is the FDA product code for PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD?

The FDA product code for PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD is LZO.

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Other records listing Orthomet, 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.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK945783ORTHOMET TITANIUM HYBRID FEMORAL STEMK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK944752ORTHOMET RESURFACING FEMORAL COMPONENTK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER

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Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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