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FDA 510(k)

HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM

K-Number: K925536 · 1994-01-07

ApplicantOrthomet, Inc.
Decision Date1994-01-07
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K925536. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM?

HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Orthomet, Inc.. The 510(k) number is K925536.

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

HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM received FDA 510(k) clearance on 1994-01-07, under 510(k) number K925536.

Who is the listed applicant for HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM?

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 HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM?

The FDA product code for HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM is KWY.

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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: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical 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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