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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002139N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00199150002146N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
00822409082131N/AOrtho Development CorporationLXH2026-07-16
00822409082148N/AOrtho Development CorporationLXH2026-07-16
00822409082155N/AOrtho Development CorporationLXH2026-07-16
00822409082162N/AOrtho Development CorporationLXH2026-07-16
00822409082179N/AOrtho Development CorporationLXH2026-07-16
00822409082186N/AOrtho Development CorporationLXH2026-07-16
00822409082193N/AOrtho Development CorporationLXH2026-07-16
00822409082209N/AOrtho Development CorporationLXH2026-07-16
00822409082216N/AOrtho Development CorporationLXH2026-07-16
00822409082223N/AOrtho Development CorporationLXH2026-07-16
00822409082230N/AOrtho Development CorporationLXH2026-07-16
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00822409082254N/AOrtho Development CorporationLXH2026-07-16
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00822409082285N/AOrtho Development CorporationLXH2026-07-16
00822409082292N/AOrtho Development CorporationLXH2026-07-16
00822409082308N/AOrtho Development CorporationLXH2026-07-16
00822409082315N/AOrtho Development CorporationLXH2026-07-16
00822409082322N/AOrtho Development CorporationLXH2026-07-16
00822409082339N/AOrtho Development CorporationLXH2026-07-16
00822409082346N/AOrtho Development CorporationLXH2026-07-16
00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188142Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188159Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16