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FDA 510(k)

OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS

K-Number: K103309 · 2011-02-03

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date2011-02-03
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEORAPTOR CURVED 2.3 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 2011-02-03 under 510(k) number K103309. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS?

OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS is a medical device that received FDA 510(k) clearance on 2011-02-03. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K103309.

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

OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS received FDA 510(k) clearance on 2011-02-03, under 510(k) number K103309.

Who is the listed applicant for OSTEORAPTOR CURVED 2.3 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 OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS?

The FDA product code for OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS is MAI.

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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.

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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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