TWINFIX 7210309

GUDID 03596010489029

TWINFIX 5.0 MM ABSORBABLE MATERIAL SUTURE ANCHOR, POLY L LACTIC ACID, WITH TWO No.2 PRELOADED DURABRAID SUTURES WITH NEEDLES, STERILE

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 03596010489029
• NIH Device Record Key: ca4a713a-bf70-4061-8f2c-84209da1c439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TWINFIX
• Version Model Number: 7210309
• Catalog Number: 7210309
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010489029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151105

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-11-03
• Device Publish Date: 2015-09-21

On-Brand Devices [TWINFIX]

• 00885556601778: SOD TWINFIX TI 3.5 THREADED
• 00885556571057: REFURBISHED TWINFIX AB 6.5MM PUNCH THR
• 00885556570395: REFURBTWNFX AB 5.0 THRD DLTR
• 00885554029291: DRILL 2.5MM FOR 3.5MM ANCHOR SL
• 00885554018424: MTO TWINFIX ULTRA 5.5 FOR 5.5 CANNULA
• 00885554018257: MTO AWL-DIL TF ULTRA 5.5/6.5 CORTICAL
• 00885554018240: MTO AWL-DILATOR TF ULTRA 4.5 CORTICAL
• 00885554015430: MTO AWL-DILATOR TWINFIX PK FT 5.5MM
• 00885554014686: TWINFIX TI 3.5 SUTURE ANCHOR PACK
• 00885554014136: TWINFIX TI 2.8 SUTURE ANCHOR PACK
• 00885554013771: MTO INLINE GUIDE 4MM TWINFIX 2.8 ANCHOR
• 00885554013146: TWINFIX AB 5.0 SUTURE ANCHOR PACK
• 00885554012835: TWINFIX TI 5.0 SUTURE ANCHOR PACK
• 03596010647641: AWL-DILATOR TWINFIX ULTRA 5.5MM
• 03596010647634: AWL-DILATOR TWINFIX ULTRA 4.5MM
• 03596010584144: AWL-DILATOR AB 5MM TWINFIX
• 03596010582690: MTO TWINFIX AB 6.5MM THREADED DIL REUSAB
• 03596010581051: TWINFIX AB 6.5 THREADED DILATOR
• 03596010581044: TWINFIX TI 5.0 QUICK-T WITH KPSC
• 03596010581013: TWINFIX TI 5.0 QUICK-T (TICRON)
• 03596010579348: TWINFIX AB 5.0 THREADED DILATOR
• 03596010481276: TWINFIX TI 5.0 QUICK-T FIXATION SYS
• 03596010448446: TWINFX TI 6.5 W/O SUTR
• 03596010448439: TWINFX TI 4.0 W/O SUTR
• 03596010448422: TWINFX TI 2.8 W/O SUTR
• 03596010448408: TWINFX TI 5.0 W/O SUTR
• 03596010000750: TWINFIX TI 3.5 QUICK-T FIXATION SYSTEM
• 03596010488114: TWINFIX 5.0 MM ABSORBABLE MATERIAL THREADED DILATOR, REUSABL
• 03596010448965: TWINFIX 2.5 MM DRILL FOR TWINFIX 4.0 MM, 5.0 MM, AND 6.5 MM
• 03596010515865: TWNFIX QUCK-T KNT PSHR STR CTR STRL BX
• 03596010516114: TWINFIX TI 3.5 QUICK-T FIXATION SYSTEM
• 03596010656131: TWINFIX ULTRA 5.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2
• 03596010619112: 2.8 MM TWINFIX TITANIUM SUTURE ANCHOR WITH 2 ULTRABRAID SUTU
• 03596010652317: TWINFIX ULTRA 5.5 MM TITANIUM ANCHOR WITH THREE No.2 SUTURES
• 03596010584472: TWINFIX 2.8 MM TITANIUM SUTURE ANCHOR WITH ONE No.2 PRELOADE
• 03596010584458: TWINFIX 2.8 MM TITANIUM SUTURE ANCHOR WITH ONE No.2 PRELOADE
• 03596010581648: TWINFIX 6.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADE
• 03596010579386: 6.5 MM TWINFIX AB SUTURE ANCHOR, PLLA, WITH TWO No.2 PRELOAD
• 03596010579379: 6.5 MM TWINFIX AB SUTURE ANCHOR, PLLA, WITH TWO No.2 PRELOAD
• 03596010578921: TWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADE
• 03596010578914: TWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADE
• 03596010578150: TWINFIX 5.0 MM ABSORBABLE MATERIAL SUTURE ANCHOR, POLY L LAC
• 03596010577993: TWINFIX 5.0 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADE
• 03596010577986: TWINFIX 5.0 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADE
• 03596010539335: TWINFIX AB 6.5 MM SUTURE ANCHOR, PLLA, WITH TWO No.2 ULTRABR
• 03596010539311: TWINFIX AB 5.0 MM SUTURE ANCHOR, PPLA, WITH TWO No.2 ULTRABR
• 03596010533845: TWINFIX 2.8 MM TITANIUM WITH 2 DURABRAID SUTURES SIZE 2-0 AN
• 03596010532213: TWINFIX 6.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADE
• 03596010532190: TWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADE
• 03596010495433: TWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADE