Q-FIX 25-2800

GUDID 00885556724644

2.8MM Q-FIX ALL SUTURE ANCHOR

Smith & Nephew, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00885556724644
• NIH Device Record Key: 1fcd7b75-047e-413e-a5f6-1824b52c66d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-FIX
• Version Model Number: 25-2800
• Catalog Number: 25-2800
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556724644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133727

FDA Product Code

• MBI: Fastener, fixation, nondegradable, 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: 3
• Public Version Date: 2019-03-21
• Device Publish Date: 2018-07-11

On-Brand Devices [Q-FIX]

• 00885556724644: 2.8MM Q-FIX ALL SUTURE ANCHOR
• 00885556724606: 1.8MM Q-FIX ALL SUTURE ANCHOR
• 00885556657461: 1.8MM QFIX REUSABLE CURVED DRILLGUIDE 24
• 00885556657454: 1.8MM QFIX RESUABLE CURVED DRILLGUIDE 12
• 00885556657447: 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL
• 00885556630815: REUSABLE 2.8MM Q-FIX DRILL GUIDE
• 00885556662618: QFIX 1.8 MINI SUTURE ANCHOR
• 00885556630792: REUSABLE 1.8MMQ-FIX OBTURATOR
• 00885556885406: 2.8MM Q-FIX ALL-SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLU
• 00885556885390: 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (BLUE
• 00885556885383: 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (COBR
• 00885556885642: Q-FIX WITH NEEDLES - MINITAPE
• 00885556885635: Q-FIX WITH NEEDLES #0 SUTURE
• 00885556885598: DRILL FOR Q-FIX WITH NEEDLES
• 00885556890790: 2.9MM CANNULATED DRILL FOR Q-FIX ULTRA & 1.25MM DRILL PIN
• 00885556890745: Q-FIX ULTRA
• 00885556630785: REUSABLE 1.8MMQ-FIX DRILL GUIDE
• 00885556630761: DISPOSABLE 1.8MM Q-FIX DRILL
• 00885556901687: Q-FIX KNOTLESS ALL-SUTURE ANCHOR 1.8MM WITH ONE ULTRABRAID SUTURE BLUE