FDA 510(k)

Smith & Nephew VISIONAIRE Adaptive Guides

K-Number: K170282 · 2017-05-22

Decision Date2017-05-22

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Smith & Nephew VISIONAIRE Adaptive Guides 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 2017-05-22 under 510(k) number K170282. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smith & Nephew VISIONAIRE Adaptive Guides?

Smith & Nephew VISIONAIRE Adaptive Guides is a medical device that received FDA 510(k) clearance on 2017-05-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K170282.

When did Smith & Nephew VISIONAIRE Adaptive Guides receive FDA 510(k) clearance?

Smith & Nephew VISIONAIRE Adaptive Guides received FDA 510(k) clearance on 2017-05-22, under 510(k) number K170282.

Who is the listed applicant for Smith & Nephew VISIONAIRE Adaptive Guides?

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 VISIONAIRE Adaptive Guides?

The FDA product code for Smith & Nephew VISIONAIRE Adaptive Guides is JWH.

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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: JWH)

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC K261032NovoKnee (SteriKnee)NovoSource K253793Materialise TKA Guide SystemMaterialise NV

Official Source

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