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FDA 510(k)

LITWIN CRUICATE ANCHOR

K-Number: K002600 · 2000-11-15

ApplicantInstrument Makar, Inc.
Decision Date2000-11-15
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LITWIN CRUICATE 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 2000-11-15 under 510(k) number K002600. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITWIN CRUICATE ANCHOR?

LITWIN CRUICATE ANCHOR is a medical device that received FDA 510(k) clearance on 2000-11-15. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K002600.

When did LITWIN CRUICATE ANCHOR receive FDA 510(k) clearance?

LITWIN CRUICATE ANCHOR received FDA 510(k) clearance on 2000-11-15, under 510(k) number K002600.

Who is the listed applicant for LITWIN CRUICATE 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 LITWIN CRUICATE ANCHOR?

The FDA product code for LITWIN CRUICATE ANCHOR is MBI.

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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.

K980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTK963396BIOSPHERE SUTURE ANCHORK964364DISPOSABLE APRONK955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHORK943249BIOABSORBABLE INTERFERENCE SCREW

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Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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