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.

00885556909393 - NA2025-10-02 Cup Impactor - Offset
00885556906941 - EVOS2025-10-01 EVOS PELVIC 3.5MM LOCKING CURVED RECON PLATE 10 HOLE
00885556907207 - EVOS2025-10-01 EVOS PELVIC 2.7MM SHORT SEGMENT CURVED UTILITY PLATE
00885556907214 - EVOS2025-10-01 EVOS PELVIC 2.7/3.5MM SHORT SEGMENT CURVED UTILITY PLATE 2 HOLE
00885556907221 - EVOS2025-10-01 EVOS PELVIC 2.7/3.5MM SHORT SEGMENT CURVED UTILITY PLATE 4 HOLE
00885556907245 - EVOS2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 6 HOLE
00885556907252 - EVOS2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 8 HOLE
00885556907290 - EVOS2025-10-01 EVOS PELVIC 2.7MM/3.5MM SYMPHYSIS LOCKING PLATE TABBED 4 HOLE

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