FDA 510(k)

COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS

K-Number: K093363 · 2010-01-26

Decision Date2010-01-26

Product CodeMBL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS 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 2010-01-26 under 510(k) number K093363. 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 COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS?

COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS is a medical device that received FDA 510(k) clearance on 2010-01-26. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K093363.

When did COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS receive FDA 510(k) clearance?

COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS received FDA 510(k) clearance on 2010-01-26, under 510(k) number K093363.

Who is the listed applicant for COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS?

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 COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS?

The FDA product code for COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS is MBL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Smith & Nephew, Inc. as applicant

K261462LANDMARK Total Knee System 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 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)

View all 509 devices →

Related Devices (Code: MBL)

K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.K182535R3 Anteverted LinersSmith & Nephew, Inc.K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.K122382DYNASTY BIOFOAM SHELLWrightmedicaltechnologyinc K113848R3 XLPE LINERSSmith & 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.