FDA.report

IdentiTi II

Primary DI
00190376722108
Brand
IdentiTi II
Company
ALPHATEC SPINE, INC.
Model
800-10225000-S
Device description
IDENTITI II LIF 10 X 22 X 50 MM, 0°
Published
2026-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K242364000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K242364000IdentiTi™ II Interbody SystemAlphatec Spine, Inc.2024-10-04MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376722108PrimaryGS10

GMDN Terms

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Device Sizes

TypeValueUnit
Height10Millimeter
Length50Millimeter
Width22Millimeter

Sterilization Methods

Method

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DIBrandCompanyProduct codePublished
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
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10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
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00840067210826TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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00840067210871TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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00840067210949TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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