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FDA 510(k)

BONE SCREWS

K-Number: K923841 · 1993-10-27

ApplicantInstrument Makar, Inc.
Decision Date1993-10-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE SCREWS 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 1993-10-27 under 510(k) number K923841. 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.

Frequently Asked Questions

What is the BONE SCREWS?

BONE SCREWS is a medical device that received FDA 510(k) clearance on 1993-10-27. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K923841.

When did BONE SCREWS receive FDA 510(k) clearance?

BONE SCREWS received FDA 510(k) clearance on 1993-10-27, under 510(k) number K923841.

Who is the listed applicant for BONE SCREWS?

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 BONE SCREWS?

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

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Other records listing Instrument Makar, Inc. 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.

K002600LITWIN CRUICATE ANCHORK980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTK963396BIOSPHERE SUTURE ANCHORK964364DISPOSABLE APRONK955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR

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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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