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FDA 510(k)

H-110 ACETABULAR CUP SYSTEM

K-Number: K926323 · 1993-05-26

ApplicantImplex Corp.
Decision Date1993-05-26
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

H-110 ACETABULAR CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K926323. 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 H-110 ACETABULAR CUP SYSTEM?

H-110 ACETABULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Implex Corp.. The 510(k) number is K926323.

When did H-110 ACETABULAR CUP SYSTEM receive FDA 510(k) clearance?

H-110 ACETABULAR CUP SYSTEM received FDA 510(k) clearance on 1993-05-26, under 510(k) number K926323.

Who is the listed applicant for H-110 ACETABULAR CUP SYSTEM?

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 H-110 ACETABULAR CUP SYSTEM?

The FDA product code for H-110 ACETABULAR CUP SYSTEM is JDI.

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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: JDI)

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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