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FDA 510(k)

BIORAPTOR 2.3 PK SUTURE ANCHOR

K-Number: K071586 · 2007-08-17

ApplicantSmith & Nephew Inc., Endoscopy Division
Decision Date2007-08-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIORAPTOR 2.3 PK SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Division. It received FDA 510(k) clearance on 2007-08-17 under 510(k) number K071586. 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 BIORAPTOR 2.3 PK SUTURE ANCHOR?

BIORAPTOR 2.3 PK SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2007-08-17. The listed applicant is Smith & Nephew Inc., Endoscopy Division. The 510(k) number is K071586.

When did BIORAPTOR 2.3 PK SUTURE ANCHOR receive FDA 510(k) clearance?

BIORAPTOR 2.3 PK SUTURE ANCHOR received FDA 510(k) clearance on 2007-08-17, under 510(k) number K071586.

Who is the listed applicant for BIORAPTOR 2.3 PK SUTURE ANCHOR?

The FDA 510(k) record lists Smith & Nephew Inc., Endoscopy Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIORAPTOR 2.3 PK SUTURE ANCHOR?

The FDA product code for BIORAPTOR 2.3 PK SUTURE ANCHOR is MBI.

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Other records listing Smith & Nephew Inc., Endoscopy Division 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.

K121904GYNECOLOGY STERILIZATION TRAYK102982ENDOBUTTON DIRECTK082215OSTEORAPTOR SUTURE ANCHORK081098ENDOBUTTON CONTINUOUS LOOP (CL)K072785TWINFIX FT PKK070908SMITH & NEPHEW KINSA RC SUTURE ANCHOR

View all 8 devices →

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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