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FDA 510(k)

OSTEONICS ALUMINA C-TAPER HEAD

K-Number: K971409 · 1997-07-09

ApplicantOsteonics Corp.
Decision Date1997-07-09
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS ALUMINA C-TAPER HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K971409. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS ALUMINA C-TAPER HEAD?

OSTEONICS ALUMINA C-TAPER HEAD is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Osteonics Corp.. The 510(k) number is K971409.

When did OSTEONICS ALUMINA C-TAPER HEAD receive FDA 510(k) clearance?

OSTEONICS ALUMINA C-TAPER HEAD received FDA 510(k) clearance on 1997-07-09, under 510(k) number K971409.

Who is the listed applicant for OSTEONICS ALUMINA C-TAPER HEAD?

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

What is the FDA product code for OSTEONICS ALUMINA C-TAPER HEAD?

The FDA product code for OSTEONICS ALUMINA C-TAPER HEAD is LZO.

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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.

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Related Devices (Code: LZO)

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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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