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FDA 510(k)

IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA

K-Number: K983835 · 1999-03-15

ApplicantImplex Corp.
Decision Date1999-03-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K983835. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA?

IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Implex Corp.. The 510(k) number is K983835.

When did IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA receive FDA 510(k) clearance?

IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA received FDA 510(k) clearance on 1999-03-15, under 510(k) number K983835.

Who is the listed applicant for IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA?

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

What is the FDA product code for IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA?

The FDA product code for IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA is JWH.

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Other records listing Implex Corp. as applicant

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Related Devices (Code: JWH)

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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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