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FDA 510(k)

PEBA ANCHOR (MULTIPLE SIZES)

K-Number: K951451 · 1995-10-31

ApplicantOrthopaedic Biosystems, Ltd.
Decision Date1995-10-31
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PEBA ANCHOR (MULTIPLE SIZES) 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 1995-10-31 under 510(k) number K951451. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PEBA ANCHOR (MULTIPLE SIZES)?

PEBA ANCHOR (MULTIPLE SIZES) is a medical device that received FDA 510(k) clearance on 1995-10-31. The listed applicant is Orthopaedic Biosystems, Ltd.. The 510(k) number is K951451.

When did PEBA ANCHOR (MULTIPLE SIZES) receive FDA 510(k) clearance?

PEBA ANCHOR (MULTIPLE SIZES) received FDA 510(k) clearance on 1995-10-31, under 510(k) number K951451.

Who is the listed applicant for PEBA ANCHOR (MULTIPLE SIZES)?

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 (MULTIPLE SIZES)?

The FDA product code for PEBA ANCHOR (MULTIPLE SIZES) 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 COMBINATIONK972326PEBA ANCHOR/SUTURE COMBINATIONK963420CANCELLOUS SCREW WASHER

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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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