FDA.reportPublic FDA data

Calibrate

Primary DI
00190376522883
Brand
Calibrate
Company
ALPHATEC SPINE, INC.
Model
261-06225020-D
Device description
LTX DOMED SPACER, 6 x 22 x 50 mm, 20°
Published
2023-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223611000Calibrate LTX Interbody SystemAlphatec Spine, Inc.2023-03-29MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376522883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376522883001903765228831903765228830190376522883

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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.

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
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
00190376544434Invictus17920-052026-07-30
00190376544441Invictus17920-062026-07-30
00190376544458Invictus17920-072026-07-30
00190376544465Invictus17920-082026-07-30
00190376544472Invictus17920-092026-07-30
00190376544489Invictus17920-102026-07-30
00190376544496Invictus179212026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606187565Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187572Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187589Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187596Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187602Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187619Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187633Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.OVD2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16