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FDA 510(k)

IMPLEX CONTINUUM POROUS PATELLAR

K-Number: K971789 · 1997-07-24

ApplicantImplex Corp.
Decision Date1997-07-24
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

IMPLEX CONTINUUM POROUS PATELLAR is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K971789. 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 IMPLEX CONTINUUM POROUS PATELLAR?

IMPLEX CONTINUUM POROUS PATELLAR is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Implex Corp.. The 510(k) number is K971789.

When did IMPLEX CONTINUUM POROUS PATELLAR receive FDA 510(k) clearance?

IMPLEX CONTINUUM POROUS PATELLAR received FDA 510(k) clearance on 1997-07-24, under 510(k) number K971789.

Who is the listed applicant for IMPLEX CONTINUUM POROUS PATELLAR?

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 POROUS PATELLAR?

The FDA product code for IMPLEX CONTINUUM POROUS PATELLAR is JWH.

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Other records listing Implex Corp. as applicant

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.

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTK051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSK040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZK040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

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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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