CrossFT CFK-475SDT

GUDID 10845854606209

CrossFT Knotless SDT 4.75 mm Suture Anchor with #2 Hi-Fi Suture

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10845854606209
• NIH Device Record Key: adb8b62f-826f-47e5-aee0-ceadefcebfec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossFT
• Version Model Number: CFK-475SDT
• Catalog Number: CFK-475SDT
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: true
• 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(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854606209 [Primary]
GS1	20845854606206 [Package]; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163258

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: 4
• Public Version Date: 2024-04-10
• Device Publish Date: 2018-08-17

On-Brand Devices [CrossFT]

• 20845854045791: CrossFT Knotless Biocomposite 4.0 mm Suture Anchor with one 2 mm Hi-Fi Tape (Blue)
• 20845854042660: CROSSFT 6.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854042653: CROSSFT 6.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854042646: CROSSFT 5.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854042639: CROSSFT 5.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/NEEDLES
• 20845854042622: 4.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854042615: CROSSFT 4.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854042608: 6.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854042592: 6.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854042585: 5.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854042578: 5.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854042561: 4.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854042554: 4.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854021825: CROSSFT 6.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854021818: CROSSFT 6.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854021801: CROSSFT 5.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854021795: CROSSFT 5.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/NEEDLES
• 20845854021788: CROSSFT 4.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854021764: CROSSFT 4.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES
• 20845854014247: 5.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854014230: 4.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854013981: 6.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854013974: 5.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854013844: 4.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854013530: 6.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
• 20845854028251: GENESYS CROSSFT PUNCH, 6.5MM
• 20845854028244: CROSSFT PUNCH, 6.5MM
• 20845854028213: CROSSFT PUNCH, 5.5MM
• 20845854028190: GENESYS CROSSFT PUNCH, 4.5MM
• 20845854028176: 4.5MM TO 6.5MM ALL IN ONE CROSSFT PUNCH
• 10845854032657: CROSSFT TAP, 6.5MM
• 10845854032633: CROSSFT TAP, 5.5MM
• 10845854032619: CROSSFT TAP, 4.5MM
• 10845854028186: CROSSFT PUNCH, 4.5MM
• 10845854044896: CrossFT Knotless 5.5 Tap
• 10845854044889: CrossFT Knotless 4.75 Tap
• 10845854044872: CrossFT Knotless 4.0 Tap
• 10845854044865: CrossFT Knotless 5.5 Broaching Punch
• 10845854044858: CrossFT Knotless 4.75 Broaching Punch
• 10845854044841: CrossFT Knotless 4.0 Broaching Punch
• 10845854606315: CrossFT™ Knotless DT 6.5 mm Suture Anchor with #2 Hi-Fi® Suture
• 10845854606230: CrossFT™ Knotless DT 6.5 mm Suture Anchor
• 10845854045107: CrossFT Knotless 4.75/5.5 Broaching Punch Disposable
• 10845854045060: CrossFT Knotless 4.75 Drill Bit, Disposable
• 10845854045053: CrossFT Knotless 4.0 Drill Bit, Disposable
• 10845854045091: CROSSFT KNOTLESS 4.0 BROACHING PUNCH, DISPOSABLE
• 10845854045077: CrossFT Knotless 5.5 Drill Bit, Disposable
• 10845854044599: CrossFT Knotless 4.0 mm Suture Anchor with one 2 mm Hi-Fi tape (White/Black)
• 10845854045800: CrossFT Knotless Biocomposite 4.0 mm Suture Anchor with one 2 mm Hi-Fi Tape (White/Black)
• 10845854045862: CrossFT Knotless Biocomposite 5.5 mm Suture Anchor with one 2 mm Hi-Fi Tape (White/Black)