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FDA 510(k)

STAPLE INSERTER-EXTRACTOR FOR ARTHROS

K-Number: K830456 · 1983-03-09

ApplicantInstrument Makar, Inc.
Decision Date1983-03-09
Product CodeHXJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAPLE INSERTER-EXTRACTOR FOR ARTHROS 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 1983-03-09 under 510(k) number K830456. The device is classified under product code HXJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAPLE INSERTER-EXTRACTOR FOR ARTHROS?

STAPLE INSERTER-EXTRACTOR FOR ARTHROS is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K830456.

When did STAPLE INSERTER-EXTRACTOR FOR ARTHROS receive FDA 510(k) clearance?

STAPLE INSERTER-EXTRACTOR FOR ARTHROS received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830456.

Who is the listed applicant for STAPLE INSERTER-EXTRACTOR FOR ARTHROS?

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 STAPLE INSERTER-EXTRACTOR FOR ARTHROS?

The FDA product code for STAPLE INSERTER-EXTRACTOR FOR ARTHROS is HXJ.

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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: HXJ)

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.

K964953IN-TAC BONE ANCHOR SYSTEMInfluence, Inc.K962372UROTAC BONE ANCHOR INSERTERInfluence, Inc.K930205ELECTRIC WIRE DRIVER, MODEL 2640EMicro Surgical Instruments Corp.K834515FIXATION STAPLE KIT - DLIDE HAMMERStryker Corp.K830255OSTEOTOMY BONE STAPLETechmedica, Inc.

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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