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FDA 510(k)

DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM

K-Number: K964704 · 1997-01-24

ApplicantDepuy, Inc.
Decision Date1997-01-24
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K964704. 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 DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM?

DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Depuy, Inc.. The 510(k) number is K964704.

When did DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM receive FDA 510(k) clearance?

DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964704.

Who is the listed applicant for DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM?

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

What is the FDA product code for DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM?

The FDA product code for DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM is LZO.

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Other records listing Depuy, Inc. as applicant

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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.

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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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