FDA.reportPublic FDA data

IdentiTi

Primary DI
00190376274133
Brand
IdentiTi
Company
ALPHATEC SPINE, INC.
Model
135-10-12161407
Device description
CERVICAL INTERFIXATED TRIAL, 12 x 16 x 14 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
00190376274133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376274133001903762741331903762741330190376274133

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Depth14Millimeter
Height12Millimeter
Width16Millimeter

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
00190376658933Valence Robotic Navigation System13010-Q-VN2026-10-29
00190376658940Valence Robotic Navigation System13010-VN2026-10-29
00190376659053Valence Robotic Navigation System13110-Q-VN2026-10-29
00190376729374Invictus Spinal Fixation System13603-01-VN2026-10-29
00190376729435Invictus Spinal Fixation System13613-01-VN2026-10-29
00190376749297Valence Robotic Navigation SystemVALPDP2026-10-29
00190376766140Valence Robotic Navigation SystemVNAVSUP2026-10-29
00190376776941Valence Robotic Navigation SystemV2MNVINN2026-10-29
00190376778358Valence Robotic Navigation SystemV2ONVINN2026-10-29
00190376632919Invictus19869-N2026-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169258MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
00841732169265MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B06234500010Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500030Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500040Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500050Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500052Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500053Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500054Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500061Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500062Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500063Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500064Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500070Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500071Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500080Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500081Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500090Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500100Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29