FDA.reportPublic FDA data

Cartiva ProxiFuse

Primary DI
00852897002007
Brand
Cartiva ProxiFuse
Company
CARTIVA, INC
Model
PRF-01
Catalog number
PRF-01
Device description
Hammer Toe Device
Published
2017-01-13
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142490000ProxiFuse Hammer Toe DeviceCartiva, Inc.2014-12-15HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852897002007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852897002007008528970020078528970020070852897002007

GMDN Terms#

Term, Definition table
TermDefinition
Interphalangeal joint arthrodesis implantA sterile implantable device designed to be inserted across a toe or finger interphalangeal joint, into the contiguous phalanges, to fuse the joint (arthrodesis), typically to correct joints damaged by traumatic, degenerative or rheumatoid arthritis, or other deformities (e.g., hammer toe), or for arthroplasty revision. It is made of metal [(e.g., stainless steel, nickel-titanium alloy (Nitinol)]) and can be of several geometric shapes (e.g., a small rod with barbs at each end, or X-shaped); devices associated with implantation may be included.

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
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
00852897002137Cartiva SCI Metatarsal Drill BitMTD-10MTD-102017-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07901125620742Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
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07901125620780Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620797Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620803Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620810Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620827Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620834Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620841Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620858Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620865Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620872Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620889Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620896Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620902Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620919Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620926Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620933Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620940Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620957Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620964Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
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07901125620551Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620568Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
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