71354176

GUDID 00885556024287

MDF TRIAL NECK STANDARD OFFSET

Smith & Nephew, Inc.

Femoral stem prosthesis trial
Primary Device ID00885556024287
NIH Device Record Key64911090-5fca-4596-b2c5-edc294a34789
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71354176
Catalog Number71354176
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556024287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


[00885556024287]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-31
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

00885556921562 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 11MM
00885556921579 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 12MM
00885556921586 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 13MM
00885556921593 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 15MM
00885556921609 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 18MM
00885556921616 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 9MM
00885556921623 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 10MM
00885556921630 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 11MM

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.