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FDA 510(k)

PEBA ANCHOR/SUTURE COMBINATION

K-Number: K972326 · 1998-02-06

ApplicantOrthopaedic Biosystems, Ltd.
Decision Date1998-02-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEBA ANCHOR/SUTURE COMBINATION is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Biosystems, Ltd.. It received FDA 510(k) clearance on 1998-02-06 under 510(k) number K972326. 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 PEBA ANCHOR/SUTURE COMBINATION?

PEBA ANCHOR/SUTURE COMBINATION is a medical device that received FDA 510(k) clearance on 1998-02-06. The listed applicant is Orthopaedic Biosystems, Ltd.. The 510(k) number is K972326.

When did PEBA ANCHOR/SUTURE COMBINATION receive FDA 510(k) clearance?

PEBA ANCHOR/SUTURE COMBINATION received FDA 510(k) clearance on 1998-02-06, under 510(k) number K972326.

Who is the listed applicant for PEBA ANCHOR/SUTURE COMBINATION?

The FDA 510(k) record lists Orthopaedic Biosystems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEBA ANCHOR/SUTURE COMBINATION?

The FDA product code for PEBA ANCHOR/SUTURE COMBINATION is MBI.

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Other records listing Orthopaedic Biosystems, Ltd. 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.

K000797OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01K982996POLYMER OBL SB ANCHOR / SUTURE COMBINATIONK983169POLYMER THREADED ANCHORK982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONK963420CANCELLOUS SCREW WASHERK963432GUIDE WIRES FOR CANNULATED SCREWS

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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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