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FDA 510(k)

SMITH & NEPHEW CIRCULAR FIXATION SYSTEM

K-Number: K093047 · 2010-09-27

ApplicantSmith & Nephew, Inc.
Decision Date2010-09-27
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW CIRCULAR FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2010-09-27 under 510(k) number K093047. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW CIRCULAR FIXATION SYSTEM?

SMITH & NEPHEW CIRCULAR FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-09-27. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K093047.

When did SMITH & NEPHEW CIRCULAR FIXATION SYSTEM receive FDA 510(k) clearance?

SMITH & NEPHEW CIRCULAR FIXATION SYSTEM received FDA 510(k) clearance on 2010-09-27, under 510(k) number K093047.

Who is the listed applicant for SMITH & NEPHEW CIRCULAR FIXATION SYSTEM?

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

What is the FDA product code for SMITH & NEPHEW CIRCULAR FIXATION SYSTEM?

The FDA product code for SMITH & NEPHEW CIRCULAR FIXATION SYSTEM is KTT.

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Other records listing Smith & Nephew, 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.

K261462LANDMARK Total Knee SystemK261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC GlenoidsK252416AETOS Shoulder System Meta Humeral Prosthesis Size 0K252129AETOS Shoulder System Stemless Humeral ProsthesisK251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

View all 509 devices →

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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