FDA.reportPublic FDA data

Cartiva SCI Introducer

Primary DI
00852897002045
Brand
Cartiva SCI Introducer
Company
CARTIVA, INC
Model
INT-08-US
Catalog number
INT-08-US
Device description
Surgical Instrument- 8 mm Introducer
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

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
00852897002045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852897002045008528970020458528970020450852897002045

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
078582549
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
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
00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523183746Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185108Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185146Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185153Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
M7409200004MIS TLIF SystemSPINEOLOGY INC.LXH2026-08-07
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31