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FDA 510(k)

INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW

K-Number: K930980 · 1994-02-10

ApplicantInstrument Makar, Inc.
Decision Date1994-02-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Instrument Makar, Inc.. It received FDA 510(k) clearance on 1994-02-10 under 510(k) number K930980. 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 INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW?

INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K930980.

When did INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW receive FDA 510(k) clearance?

INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW received FDA 510(k) clearance on 1994-02-10, under 510(k) number K930980.

Who is the listed applicant for INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW?

The FDA 510(k) record lists Instrument Makar, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW?

The FDA product code for INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Instrument Makar, Inc. as applicant

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Related Devices (Code: HWC)

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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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