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FDA 510(k)

H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED

K-Number: K901626 · 1990-08-14

ApplicantMed-Tek Corp.
Decision Date1990-08-14
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tek Corp.. It received FDA 510(k) clearance on 1990-08-14 under 510(k) number K901626. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED?

H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED is a medical device that received FDA 510(k) clearance on 1990-08-14. The listed applicant is Med-Tek Corp.. The 510(k) number is K901626.

When did H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED receive FDA 510(k) clearance?

H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED received FDA 510(k) clearance on 1990-08-14, under 510(k) number K901626.

Who is the listed applicant for H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED?

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

What is the FDA product code for H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED?

The FDA product code for H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED is KWA.

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Other records listing Med-Tek 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.

K903234F-19 TOTAL HIP PROSTHESISK901687F-24 FEMORAL HIP PROSTHESISK901451F-20 CEMENTED METAL-BACKED ACETABULAR CUPK900428ANESTHESIA BREATHING CIRCUITSK901594H.N. TOTAL HIP PROSTHESISK901480F-20 TOTAL HIP PROSTHESIS

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Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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