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FDA 510(k)

SPACER G TEMPORARY HIP PROSTHESIS

K-Number: K031841 · 2004-01-22

ApplicantExactech, Inc.
Decision Date2004-01-22
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPACER G TEMPORARY HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2004-01-22 under 510(k) number K031841. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACER G TEMPORARY HIP PROSTHESIS?

SPACER G TEMPORARY HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is Exactech, Inc.. The 510(k) number is K031841.

When did SPACER G TEMPORARY HIP PROSTHESIS receive FDA 510(k) clearance?

SPACER G TEMPORARY HIP PROSTHESIS received FDA 510(k) clearance on 2004-01-22, under 510(k) number K031841.

Who is the listed applicant for SPACER G TEMPORARY HIP PROSTHESIS?

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

What is the FDA product code for SPACER G TEMPORARY HIP PROSTHESIS?

The FDA product code for SPACER G TEMPORARY HIP PROSTHESIS is KWL.

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Related Devices (Code: KWL)

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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