Cartiva Synthetic Cartilage Implant

Basic Information

• Brand Name: Cartiva Synthetic Cartilage Implant
• Primary DI: 00852897002335
• Version / Model: CAR-12-US
• Catalog Number: CAR-12-US
• Company Name: CARTIVA, INC
• Labeler DUNS: 078582549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-13
• Public Version: 2
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 899d9799-1885-4007-9a51-e50823f932bf

Device Description

12 mm Synthetic Cartilage Implant

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNW	Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33700	Total metatarsophalangeal joint prosthesis, one-piece	An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852897002335	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P150017	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 49 Degrees Celsius