PORK-15 71425301

GUDID 00885556732946

POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 1 RIGHT

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, metallic
Primary Device ID00885556732946
NIH Device Record Key1a070c9a-4a07-4cdb-9593-2c46929f3b87
Commercial Distribution StatusIn Commercial Distribution
Brand NamePORK-15
Version Model Number71425301
Catalog Number71425301
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556732946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-18
Device Publish Date2021-10-08

Devices Manufactured by Smith & Nephew, Inc.

00885556538418 - Legion2025-07-25 LEGION FINNED TIBIAL WEDGE SIZE4 20MM LEFT
00885556538401 - Legion2025-07-23 LEGION FINNED TIBIAL WEDGE SIZE4 15MM LEFT
00885556915875 - DIRECT VIEW AND VIDEO SCOPES2025-07-01 4KO VIDIOARTHROSCOPE AC 4 X 30 DEG X 160MM REVERSE POST
00885556915882 - DIRECT VIEW AND VIDEO SCOPE2025-07-01 4KO VIDEOARTHROSCOPE AC 4 X 70 DEG X 160MM REVERSE POST
00885556915899 - DIRECT VIEW AND VIDEO SCOPES2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4X 30 DEG X 160MM REVERSE POST
00885556915905 - DIRECT VIEW AND VIDEO SCOPE2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4 X 70 DEG X 160MM RND TIP REV POST
00885556900284 - TRIGEN MAX2025-06-10 TRIGEN MAX 13MM WASHER
00885556901960 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 26MM CORTEX SCREW BLUNT TIP

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