FDA 510(k)

LEGION Inserts with JRNY Lock

K-Number: K200407 · 2020-03-13

Decision Date2020-03-13

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LEGION Inserts with JRNY Lock 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 2020-03-13 under 510(k) number K200407. 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 LEGION Inserts with JRNY Lock?

LEGION Inserts with JRNY Lock is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K200407.

When did LEGION Inserts with JRNY Lock receive FDA 510(k) clearance?

LEGION Inserts with JRNY Lock received FDA 510(k) clearance on 2020-03-13, under 510(k) number K200407.

Who is the listed applicant for LEGION Inserts with JRNY Lock?

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 LEGION Inserts with JRNY Lock?

The FDA product code for LEGION Inserts with JRNY Lock 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.