Cartiva ProxiFuse PRF-01

GUDID 00852897002007

Hammer Toe Device

CARTIVA, INC

Interphalangeal joint arthrodesis implant

• Primary Device ID: 00852897002007
• NIH Device Record Key: cda8e889-9bcb-463a-85fb-84ae3599f79b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cartiva ProxiFuse
• Version Model Number: PRF-01
• Catalog Number: PRF-01
• Company DUNS: 078582549
• Company Name: CARTIVA, 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: 770-754-3800
• Email: info@cartiva.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852897002007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142490

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2018-07-06
• Device Publish Date: 2017-01-13

Devices Manufactured by CARTIVA, INC

• 00850013558018 - Cartiva MTP Sizer: 2021-02-03 Surgical Instrument- Measurement Tool
• 00852897002953 - Cartiva SCI Metatarsal Drill Bit: 2020-06-23 Surgical Instrument- 12 mm Metatarsal Drill Bit
• 00852897002960 - Cartiva SCI Placer: 2020-06-23 Surgical Instrument- 12 mm Placer
• 00852897002984 - Cartiva SCI Metatarsal Drill Bit: 2020-06-23 Surgical Instrument- 6 mm Metatarsal Drill Bit
• 00852897002991 - Cartiva SCI Placer: 2020-06-23 Surgical Instrument- 6 mm Placer
• 00852897002021 - Cartiva Synthetic Cartilage Implant: 2020-06-23 8 mm Synthetic Cartilage Implant
• 00852897002038 - Cartiva Synthetic Cartilage Implant: 2020-06-23 10 mm Synthetic Cartilage Implant
• 00852897002106 - Cartiva SCI Introducer: 2020-06-23 Surgical Instrument- 8 mm Introducer