FDA.reportPublic FDA data

IdentiTi

Primary DI
00190376286242
Brand
IdentiTi
Company
ALPHATEC SPINE, INC.
Model
134-07201610-S
Device description
IDENTITi CERVICAL SA SPACER, 7 x 20 x 16 mm, 10°
Published
2021-03-31
Public version status
Update
Distribution status
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
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
00190376286242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376286242001903762862421903762862420190376286242

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle10degree
Depth16Millimeter
Height7Millimeter
Width20Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
602465783
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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