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FDA 510(k)

UNILOC-CEMENTLESS & SELF TAP ACETABULAR

K-Number: K842518 · 1985-01-30

ApplicantAmerican Ortomed Corp.
Decision Date1985-01-30
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNILOC-CEMENTLESS & SELF TAP ACETABULAR is the device name listed in this FDA 510(k) record. The listed applicant is American Ortomed Corp.. It received FDA 510(k) clearance on 1985-01-30 under 510(k) number K842518. 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 UNILOC-CEMENTLESS & SELF TAP ACETABULAR?

UNILOC-CEMENTLESS & SELF TAP ACETABULAR is a medical device that received FDA 510(k) clearance on 1985-01-30. The listed applicant is American Ortomed Corp.. The 510(k) number is K842518.

When did UNILOC-CEMENTLESS & SELF TAP ACETABULAR receive FDA 510(k) clearance?

UNILOC-CEMENTLESS & SELF TAP ACETABULAR received FDA 510(k) clearance on 1985-01-30, under 510(k) number K842518.

Who is the listed applicant for UNILOC-CEMENTLESS & SELF TAP ACETABULAR?

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

What is the FDA product code for UNILOC-CEMENTLESS & SELF TAP ACETABULAR?

The FDA product code for UNILOC-CEMENTLESS & SELF TAP ACETABULAR is KWA.

Related Clinical Trials

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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Other records listing American Ortomed 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.

K842466TITANIUM MITTELMEIER TYPE ACETABULARK842465UNILOCK840413CEMENT RESTRICTORK820719THE ICR KNEEK780497SPHERISTEM TOTAL HIP PROSTHESIS

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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