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FDA 510(k)

BIODEGRADABLE SURGICAL STAPLE

K-Number: K910723 · 1991-03-12

ApplicantInstrument Makar, Inc.
Decision Date1991-03-12
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIODEGRADABLE SURGICAL STAPLE 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 1991-03-12 under 510(k) number K910723. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODEGRADABLE SURGICAL STAPLE?

BIODEGRADABLE SURGICAL STAPLE is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K910723.

When did BIODEGRADABLE SURGICAL STAPLE receive FDA 510(k) clearance?

BIODEGRADABLE SURGICAL STAPLE received FDA 510(k) clearance on 1991-03-12, under 510(k) number K910723.

Who is the listed applicant for BIODEGRADABLE SURGICAL STAPLE?

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 BIODEGRADABLE SURGICAL STAPLE?

The FDA product code for BIODEGRADABLE SURGICAL STAPLE is JDR.

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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: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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