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FDA 510(k)

OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS

K-Number: K894124 · 1989-09-11

ApplicantOsteonics Corp.
Decision Date1989-09-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1989-09-11 under 510(k) number K894124. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS?

OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS is a medical device that received FDA 510(k) clearance on 1989-09-11. The listed applicant is Osteonics Corp.. The 510(k) number is K894124.

When did OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS receive FDA 510(k) clearance?

OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS received FDA 510(k) clearance on 1989-09-11, under 510(k) number K894124.

Who is the listed applicant for OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS?

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 OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS?

The FDA product code for OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS is HWC. This falls under the Cardiovascular category.

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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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Related Devices (Code: HWC)

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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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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