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FDA 510(k)

HS4 HEAD/NECK FEMORAL PROSTHESES

K-Number: K833461 · 1983-12-27

ApplicantOsteonics Corp.
Decision Date1983-12-27
Product Code
DecisionSubstantially Equivalent

Device Summary

HS4 HEAD/NECK FEMORAL PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833461. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HS4 HEAD/NECK FEMORAL PROSTHESES?

HS4 HEAD/NECK FEMORAL PROSTHESES is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Osteonics Corp.. The 510(k) number is K833461.

When did HS4 HEAD/NECK FEMORAL PROSTHESES receive FDA 510(k) clearance?

HS4 HEAD/NECK FEMORAL PROSTHESES received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833461.

Who is the listed applicant for HS4 HEAD/NECK FEMORAL PROSTHESES?

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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