Cartiva ProxiFuse PRF-01

GUDID 00852897002007

Hammer Toe Device

CARTIVA, INC

Interphalangeal joint arthrodesis implant
Primary Device ID00852897002007
NIH Device Record Keycda8e889-9bcb-463a-85fb-84ae3599f79b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCartiva ProxiFuse
Version Model NumberPRF-01
Catalog NumberPRF-01
Company DUNS078582549
Company NameCARTIVA, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100852897002007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-13

Devices Manufactured by CARTIVA, INC

00850013558018 - Cartiva MTP Sizer2021-02-03 Surgical Instrument- Measurement Tool
00852897002953 - Cartiva SCI Metatarsal Drill Bit2020-06-23 Surgical Instrument- 12 mm Metatarsal Drill Bit
00852897002960 - Cartiva SCI Placer2020-06-23 Surgical Instrument- 12 mm Placer
00852897002984 - Cartiva SCI Metatarsal Drill Bit2020-06-23 Surgical Instrument- 6 mm Metatarsal Drill Bit
00852897002991 - Cartiva SCI Placer2020-06-23 Surgical Instrument- 6 mm Placer
00852897002021 - Cartiva Synthetic Cartilage Implant2020-06-23 8 mm Synthetic Cartilage Implant
00852897002038 - Cartiva Synthetic Cartilage Implant2020-06-23 10 mm Synthetic Cartilage Implant
00852897002106 - Cartiva SCI Introducer2020-06-23 Surgical Instrument- 8 mm Introducer
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