Ti6 Internal Fixation System TC4028

GUDID 00885556835999

TI6 LOW PROFILE 4.0MM X 28MM BONE SCREW

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00885556835999
NIH Device Record Key26d74306-893a-4f28-b69a-0bf045d6e55e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi6 Internal Fixation System
Version Model NumberTC4028
Catalog NumberTC4028
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 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)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
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556835999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

[00885556835999]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-24
Device Publish Date2022-12-22

On-Brand Devices [Ti6 Internal Fixation System]

00885556835227BONE REDUCTION FORCEPS SERRATED
00885556835210BONE REDUCTION FORCEPS SWEETHEART STYLE
00885556835500TQSERIES QUICKSNAP 3PRONG DRIVER SHAFT
00885556835494THSERIES REMOVAL DRIVER SHAFT
00885556835470THSERIES CANN. DEPTH GAUGE
00885556835463THSERIES CANN. DRIVER SHAFT
00885556835432TCSERIES CANN. DEPTH GAUGE/CSINK. 3.0/4.0MM SCREWS
00885556835425TCSERIES CANN. DEPTH GAUGE/CSINK. 2.0/2.5MM SCREWS
00885556835418TCSERIES 3.0 / 4.0MM CANNULATED DRIVER SHAFT
00885556835401TCSERIES 2.0 / 2.5MM CANNULATED DRIVER SHAFT
00885556835395TS-SERIES COUNTERSINK FOR 3.0 & 4.0MM SCREWS - AO
00885556835388TS-SERIES COUNTERSINK FOR 3.0 & 4.0MM SCREWS
00885556835371TS-SERIES COUNTERSINK FOR 2.0 & 2.5MM SCREWS - AO
00885556835364TS-SERIES COUNTERSINK FOR 2.0 & 2.5MM SCREWS
00885556835357TSSERIES DRILL GUIDE FOR 3.0 & 4.0MM SCREWS
00885556835340TSSERIES DRILL GUIDE FOR 2.0 & 2.5MM SCREWS
00885556835319TSSERIES 3.0 / 4.0MM DRIVER SHAFT
00885556835302TSSERIES 2.0 / 2.5MM DRIVER SHAFT
00885556835258SCREW REMOVAL TOOL
00885556835241SCREW PICKUP FORCEPS
00885556835234BONE REDUCTION FORCEPS SCARF
00885556835197TITANIUM SWIVEL DRIVER HANDLE
00885556835180TI6 DIGITAL FUSION DRIVER SHAFT
00885556835036TI6 DIGITAL SCREW COUNTERSINKDEPTH GAUGE
00885556836156TI6 HEADLESS 2.5MM X 22MM BONE SCREW
00885556836149TI6 HEADLESS 2.5MM X 20MM BONE SCREW
00885556836132TI6 HEADLESS 2.5MM X 18MM BONE SCREW
00885556836125TI6 HEADLESS 2.5MM X 16MM BONE SCREW
00885556836118TI6 HEADLESS 2.5MM X 14MM BONE SCREW
00885556836101TI6 HEADLESS 2.5MM X 12MM BONE SCREW
00885556836095TI6 HEADLESS 2.5MM X 10MM BONE SCREW
00885556836088TI6 LOW PROFILE 4.0MM X 50MM BONE SCREW
00885556836071TI6 LOW PROFILE 4.0MM X 46MM BONE SCREW
00885556836064TI6 LOW PROFILE 4.0MM X 42MM BONE SCREW
00885556836057TI6 LOW PROFILE 4.0MM X 40MM BONE SCREW
00885556836040TI6 LOW PROFILE 4.0MM X 38MM BONE SCREW
00885556836033TI6 LOW PROFILE 4.0MM X 36MM BONE SCREW
00885556836026TI6 LOW PROFILE 4.0MM X 34MM BONE SCREW
00885556836019TI6 LOW PROFILE 4.0MM X 32MM BONE SCREW
00885556836002TI6 LOW PROFILE 4.0MM X 30MM BONE SCREW
00885556835999TI6 LOW PROFILE 4.0MM X 28MM BONE SCREW
00885556835982TI6 LOW PROFILE 4.0MM X 26MM BONE SCREW
00885556835975TI6 LOW PROFILE 4.0MM X 24MM BONE SCREW
00885556835968TI6 LOW PROFILE 4.0MM X 22MM BONE SCREW
00885556835951TI6 LOW PROFILE 4.0MM X 20MM BONE SCREW
00885556835944TI6 LOW PROFILE 4.0MM X 18MM BONE SCREW
00885556835937TI6 LOW PROFILE 4.0MM X 16MM BONE SCREW
00885556835913TI6 LOW PROFILE 4.0MM X 12MM BONE SCREW
00885556835890TI6 LOW PROFILE 3.0MM X 36MM BONE SCREW
00885556835883TI6 LOW PROFILE 3.0MM X 34MM BONE SCREW
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.