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FDA 510(k)

BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR

K-Number: K960555 · 1996-07-09

ApplicantInstrument Makar, Inc.
Decision Date1996-07-09
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR 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 1996-07-09 under 510(k) number K960555. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR?

BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1996-07-09. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K960555.

When did BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR receive FDA 510(k) clearance?

BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR received FDA 510(k) clearance on 1996-07-09, under 510(k) number K960555.

Who is the listed applicant for BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR?

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 BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR?

The FDA product code for BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR is MAI.

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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-HIGHK943249BIOABSORBABLE INTERFERENCE SCREW

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Related Devices (Code: MAI)

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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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