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FDA 510(k)

NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)

K-Number: K011904 · 2001-07-19

ApplicantImplex Corp.
Decision Date2001-07-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2001-07-19 under 510(k) number K011904. 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 NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)?

NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) is a medical device that received FDA 510(k) clearance on 2001-07-19. The listed applicant is Implex Corp.. The 510(k) number is K011904.

When did NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) receive FDA 510(k) clearance?

NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) received FDA 510(k) clearance on 2001-07-19, under 510(k) number K011904.

Who is the listed applicant for NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)?

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 NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)?

The FDA product code for NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) is 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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