FDA.reportPublic FDA data

Cartiva Synthetic Cartilage Implant

Primary DI
00852897002335
Brand
Cartiva Synthetic Cartilage Implant
Company
CARTIVA, INC
Model
CAR-12-US
Catalog number
CAR-12-US
Device description
12 mm Synthetic Cartilage Implant
Published
2019-12-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNWProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNWProsthesis, Metatarsophalangeal Joint Cartilage Replacement ImplantUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150017000CARTIVA SYNTHETIC CARTILAGE IMPLANTCartiva, Inc.2016-07-01PNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852897002335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852897002335008528970023358528970023350852897002335

GMDN Terms#

Term, Definition table
TermDefinition
Total metatarsophalangeal joint prosthesis, one-pieceA sterile 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius49 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-754-3800info@cartiva.net

Regulatory Flags#

DUNS number
078582549
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852897002007Cartiva ProxiFusePRF-01PRF-012017-01-13
00852897002014Cartiva Rasp DeviceRAS-08RAS-082017-01-13
00850013558018Cartiva MTP SizerMTPSZR-00MTPSZR-002021-01-26
00852897002342Cartiva Disposable Instrument SetMTS-08MTS-082019-12-13
00852897002359Cartiva Disposable Instrument SetMTS-10MTS-102019-12-13
00852897002946Cartiva SCI IntroducerINT-12INT-122019-12-13
00852897002953Cartiva SCI Metatarsal Drill BitMTD-12MTD-122019-12-13
00852897002960Cartiva SCI PlacerPLC-12PLC-122019-12-13
00852897002977Cartiva SCI IntroducerINT-06-G1INT-06-G12019-12-13
00852897002984Cartiva SCI Metatarsal Drill BitMTD-06-G1MTD-06-G12019-12-13
00852897002991Cartiva SCI PlacerPLC-06-G1PLC-06-G12019-12-13
00852897002045Cartiva SCI IntroducerINT-08-USINT-08-US2017-01-13
00852897002052Cartiva SCI IntroducerINT-10-USINT-10-US2017-01-13
00852897002069Cartiva SCI Metatarsal Drill BitMTD-08-USMTD-08-US2017-01-13
00852897002076Cartiva SCI Metatarsal Drill BitMTD-10-USMTD-10-US2017-01-13
00852897002083Cartiva SCI PlacerPLC-08-USPLC-08-US2017-01-13
00852897002090Cartiva SCI PlacerPLC-10-USPLC-10-US2017-01-13
00852897002106Cartiva SCI IntroducerINT-08INT-082017-01-13
00852897002113Cartiva SCI IntroducerINT-10INT-102017-01-13
00852897002120Cartiva SCI Metatarsal Drill BitMTD-08MTD-082017-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852897002328Cartiva Synthetic Cartilage ImplantCARTIVA, INCPNW2019-12-13
00852897002021Cartiva Synthetic Cartilage ImplantCARTIVA, INCPNW2017-01-13
00852897002038Cartiva Synthetic Cartilage ImplantCARTIVA, INCPNW2017-01-13