FDA.reportPublic FDA data

IdentiTi

Primary DI
00190376273389
Brand
IdentiTi
Company
ALPHATEC SPINE, INC.
Model
135-10-10141207
Device description
CERVICAL INTERFIXATED TRIAL, 10 x 14 x 12 mm, 7°
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202812000IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.2020-12-18OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376273389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376273389001903762733891903762733890190376273389

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Depth12Millimeter
Height10Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840967110981AlphaGRAFT1002-1002015-09-24
00840967110998AlphaGRAFT1001-0102015-09-24
00840967111001AlphaGRAFT1001-1002015-09-24
00844856026711AlphaGRAFT1001-0502015-09-24
00844856026728AlphaGRAFT1002-0252015-09-24
00844856026735AlphaGRAFT1002-0502015-09-24
00844856032231Osseofix +213902016-10-28
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25
00190376652337CONTOUR3DAIX761042026-09-25
00190376668307CONTOUR3DAIX760002026-09-25
00190376733470CONTOUR3DC3DRODA2026-09-25
00190376778372InvictusVMRIN2026-08-19
00190376778396InvictusVMTIN2026-08-19
00190376768847Invictus171442026-08-17
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889981124390Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124406Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124413Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124420Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124437Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124444Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124451Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124468Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142301Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142318Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142325Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142332Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142349Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142356Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142363Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142462Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142479Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142486Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142493Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142509Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142516Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142523Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124888Shoreline ACSSeaspine Orthopedics CorporationOVE2018-04-18
00889981124994Shoreline ACSSeaspine Orthopedics CorporationOVE2018-04-18
00889981125007Shoreline ACSSeaspine Orthopedics CorporationOVE2018-04-18
00889981125014Shoreline ACSSeaspine Orthopedics CorporationOVE2018-04-18
00889981125021Shoreline ACSSeaspine Orthopedics CorporationOVE2018-04-18
00889981125038Shoreline ACSSeaspine Orthopedics CorporationOVE2018-04-18
00889981124017Shoreline ACSSeaspine Orthopedics CorporationOVE2017-06-20
00889981124024Shoreline ACSSeaspine Orthopedics CorporationOVE2017-06-20