FDA.reportPublic FDA data

Ascend

Primary DI
00190376518060
Brand
Ascend
Company
ALPHATEC SPINE, INC.
Model
156-12-410-50
Device description
CV VBR 12 mm CORE HT Trial, 50-80 mm
Published
2024-10-28
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
PLRSpinal vertebral body replacement device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232173000Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.2023-10-06MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376518060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376518060001903765180601903765180600190376518060

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Height50Millimeter
Height80Millimeter

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
10888857461819CASCADIA™ Interbody SystemVB Spine LLCPLR2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCPLR2019-10-31
10888857023482SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-14
10888857023499SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023734SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023741SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023758SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023765SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023772SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023789SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023796SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023802SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023819SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023826SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023833SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023840SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023857SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023864SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023871SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023888SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-13
10888857023314SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023475SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023567SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023673SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023680SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023697SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023703SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023710SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857023727SANTORINI™ Corpectomy Cage SystemVB Spine LLCPLR2018-12-10
10888857160460CASCADIA™ Interbody SystemVB Spine LLCPLR2018-04-16