FDA 510(k)

R3 HA Coated Acetabular Shells

K-Number: K201701 · 2020-10-06

Decision Date2020-10-06

Product CodeMBL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

R3 HA Coated Acetabular Shells 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 2020-10-06 under 510(k) number K201701. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R3 HA Coated Acetabular Shells?

R3 HA Coated Acetabular Shells is a medical device that received FDA 510(k) clearance on 2020-10-06. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K201701.

When did R3 HA Coated Acetabular Shells receive FDA 510(k) clearance?

R3 HA Coated Acetabular Shells received FDA 510(k) clearance on 2020-10-06, under 510(k) number K201701.

Who is the listed applicant for R3 HA Coated Acetabular Shells?

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 R3 HA Coated Acetabular Shells?

The FDA product code for R3 HA Coated Acetabular Shells is MBL.

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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: MBL)

K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.K182535R3 Anteverted LinersSmith & Nephew, Inc.K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.

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.