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FDA 510(k)

BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS

K-Number: K102660 · 2010-12-13

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date2010-12-13
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 2010-12-13 under 510(k) number K102660. 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 CURVED 2.3 PK SUTURE ANCHORS?

BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS is a medical device that received FDA 510(k) clearance on 2010-12-13. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K102660.

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

BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS received FDA 510(k) clearance on 2010-12-13, under 510(k) number K102660.

Who is the listed applicant for BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS?

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

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

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

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Other records listing Smith & Nephew Endoscopy, 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.

K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSK093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORK083226SMITH & NEPHEW PEEK INTERFERENCE SCREWK083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWK082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICEK050580SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS

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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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