72710565

GUDID 00885556895108

TRIGEN MAX 5.0MM HEADLESS LOCKING SCREW - 65MM

Smith & Nephew, Inc.

Orthopaedic bone screw (non-sliding)
Primary Device ID00885556895108
NIH Device Record Key09fc14ec-d847-498a-95bf-ee320ca63ba7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number72710565
Catalog Number72710565
Company DUNS045483575
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -
Special Storage Condition, SpecifyBetween 0 and 0 *: -

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556895108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-19
Device Publish Date2025-05-09

Devices Manufactured by Smith & Nephew, Inc.

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
00885556901977 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 28MM CORTEX SCREW BLUNT TIP
00885556901984 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 30MM CORTEX SCREW BLUNT TIP

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