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FDA 510(k)

OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE

K-Number: K864372 · 1986-11-25

ApplicantOsteonics Corp.
Decision Date1986-11-25
Product Code
DecisionSubstantially Equivalent

Device Summary

OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1986-11-25 under 510(k) number K864372. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE?

OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE is a medical device that received FDA 510(k) clearance on 1986-11-25. The listed applicant is Osteonics Corp.. The 510(k) number is K864372.

When did OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE receive FDA 510(k) clearance?

OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE received FDA 510(k) clearance on 1986-11-25, under 510(k) number K864372.

Who is the listed applicant for OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE?

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

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Other records listing Osteonics 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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