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FDA 510(k)

FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA

K-Number: K973672 · 1997-12-18

ApplicantEncore Orthopedics, Inc.
Decision Date1997-12-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1997-12-18 under 510(k) number K973672. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA?

FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K973672.

When did FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA receive FDA 510(k) clearance?

FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA received FDA 510(k) clearance on 1997-12-18, under 510(k) number K973672.

Who is the listed applicant for FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA?

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

What is the FDA product code for FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA?

The FDA product code for FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA is JWH.

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Other records listing Encore Orthopedics, Inc. as applicant

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Related Devices (Code: JWH)

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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