TWINFIX/ULTRABRAID 7210712

GUDID 03596010539328

TWINFIX 6.5AB PRLD STR ANCHR W/NEEDLES

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 03596010539328
• NIH Device Record Key: 75cbdd1e-8811-4a47-b4e0-91629a54c687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TWINFIX/ULTRABRAID
• Version Model Number: 7210712
• Catalog Number: 7210712
• Company DUNS: 045483575
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010539328 [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: 2023-09-07
• Device Publish Date: 2015-09-21

On-Brand Devices [TWINFIX/ULTRABRAID]

• 03596010584465: TWINFIX TI 2.8 DURABRAID (1)
• 03596010579362: TWNFX AB 5.0STR ANCR 2 38 ULTR THR DILTR
• 03596010539304: TWINFIX 5.0AB STR ANCHR W/2STR &NDLS
• 03596010532206: TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N
• 03596010505125: TWINFIX TI 5.0 STR ANCHR W/2 ULTRBRD S
• 03596010502414: TWINFIX TI 2.8 ANCH W/1 ULTRABRAID SU
• 03596010539328: TWINFIX 6.5AB PRLD STR ANCHR W/NEEDLES
• 03596010502445: TWINFIX TI 6.5 STR ANCHR W/2 ULTRBRD S