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FDA 510(k)

HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ

K-Number: K001759 · 2000-08-24

ApplicantImplex Corp.
Decision Date2000-08-24
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2000-08-24 under 510(k) number K001759. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ?

HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ is a medical device that received FDA 510(k) clearance on 2000-08-24. The listed applicant is Implex Corp.. The 510(k) number is K001759.

When did HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ receive FDA 510(k) clearance?

HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ received FDA 510(k) clearance on 2000-08-24, under 510(k) number K001759.

Who is the listed applicant for HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ?

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 HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ?

The FDA product code for HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ is JDI.

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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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