FDA.report

IdentiTi

Primary DI
00190376220567
Brand
IdentiTi
Company
ALPHATEC SPINE, INC.
Model
121-12092220
Device description
IDENTITi PS POROUS Ti TRIAL, 12 X 9 X 22 mm, 20°
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K241375000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241375000IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec CerAlphatec Spine2025-02-03MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376220567PrimaryGS10

GMDN Terms

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

TypeValueUnit
Angle20degree
Height12Millimeter
Length22Millimeter
Width9Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags

DUNS number
602465783
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190376509747SafeOp 3AIX118142026-03-24
00840180539521General InstrumentsCI-11843-082025-10-17
00840180541173General InstrumentsCI-11872-1002025-10-17
00840180541180General InstrumentsCI-11872-2002025-10-17
00840180541197General InstrumentsCI-11872-3002025-10-17
00840180541203General InstrumentsCI-11872-4002025-10-17
00190376633428Valence Robotic Navigation System525-10202026-02-26
00190376633435Valence Robotic Navigation System525-10302026-02-26
00190376633442Valence Robotic Navigation System525-1050-0952026-02-26
00190376633459Valence Robotic Navigation System525-1050-1252026-02-26
00190376633466Valence Robotic Navigation System525-1050-1502026-02-26
00190376633473Valence Robotic Navigation System525-10702026-02-26
00190376633480Valence Robotic Navigation System525-10902026-02-26
00190376633497Valence Robotic Navigation System525-10912026-02-26
00190376633503Valence Robotic Navigation System525-11002026-02-26
00190376633510Valence Robotic Navigation System525-11012026-02-26
00190376633527Valence Robotic Navigation System525-11102026-02-26
00190376633534Valence Robotic Navigation System525-10402026-02-26
00190376634340Valence Robotic Navigation System525-10412026-02-26
00190376643670Valence Robotic Navigation System525-10602026-02-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840283403187LumiVy™VY SPINE LLCMAX2026-03-24
00840283403194LumiVy™VY SPINE LLCMAX2026-03-24
00840283403200LumiVy™VY SPINE LLCMAX2026-03-24
00840283403217LumiVy™VY SPINE LLCMAX2026-03-24
00840283403224LumiVy™VY SPINE LLCMAX2026-03-24
06009527200096TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200102TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200119TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200126TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200133TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200140TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200157TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200164TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200218TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200225TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200232TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200249TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200256TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200263TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
03662663130929Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
03662663130936Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
03662663131117Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
04052536018192pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018208pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018215pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018222pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018239pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018246pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018253pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018260pezoUlrich GmbH & Co. KGMAX2026-03-16