FDA 510(k)

Circular Fixation with Balanced Cable Transport

K-Number: K202762 · 2020-11-16

Decision Date2020-11-16

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Circular Fixation with Balanced Cable Transport 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 2020-11-16 under 510(k) number K202762. 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 Circular Fixation with Balanced Cable Transport?

Circular Fixation with Balanced Cable Transport is a medical device that received FDA 510(k) clearance on 2020-11-16. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K202762.

When did Circular Fixation with Balanced Cable Transport receive FDA 510(k) clearance?

Circular Fixation with Balanced Cable Transport received FDA 510(k) clearance on 2020-11-16, under 510(k) number K202762.

Who is the listed applicant for Circular Fixation with Balanced Cable Transport?

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 Circular Fixation with Balanced Cable Transport?

The FDA product code for Circular Fixation with Balanced Cable Transport is KTT.

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-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 Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 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)

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Related Devices (Code: KTT)

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC K260900DYNEX® External Fixation SystemsVilex, LLC K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean Global K253613Monkey 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.