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FDA 510(k)

ORTHOMET LHMC FEMORAL STEM

K-Number: K931678 · 1994-10-14

ApplicantOrthomet, Inc.
Decision Date1994-10-14
Product CodeHMC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORTHOMET LHMC FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1994-10-14 under 510(k) number K931678. The device is classified under product code HMC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOMET LHMC FEMORAL STEM?

ORTHOMET LHMC FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1994-10-14. The listed applicant is Orthomet, Inc.. The 510(k) number is K931678.

When did ORTHOMET LHMC FEMORAL STEM receive FDA 510(k) clearance?

ORTHOMET LHMC FEMORAL STEM received FDA 510(k) clearance on 1994-10-14, under 510(k) number K931678.

Who is the listed applicant for ORTHOMET LHMC FEMORAL STEM?

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 ORTHOMET LHMC FEMORAL STEM?

The FDA product code for ORTHOMET LHMC FEMORAL STEM is HMC.

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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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Official Source

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

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