FDA 510(k)

REDAPT Anteverted Cemented Liner

K-Number: K160923 · 2016-11-17

Decision Date2016-11-17

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REDAPT Anteverted Cemented Liner 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 2016-11-17 under 510(k) number K160923. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDAPT Anteverted Cemented Liner?

REDAPT Anteverted Cemented Liner is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K160923.

When did REDAPT Anteverted Cemented Liner receive FDA 510(k) clearance?

REDAPT Anteverted Cemented Liner received FDA 510(k) clearance on 2016-11-17, under 510(k) number K160923.

Who is the listed applicant for REDAPT Anteverted Cemented Liner?

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 REDAPT Anteverted Cemented Liner?

The FDA product code for REDAPT Anteverted Cemented Liner is JDI.

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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: JDI)

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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.