FDA.reportPublic FDA data

Ascend

Primary DI
00190376519432
Brand
Ascend
Company
ALPHATEC SPINE, INC.
Model
153-12-L-202500-S
Device description
12 mm CORE ENDPLATE, LAT 20 x 25 mm 0°
Published
2024-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00190376519432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376519432001903765194321903765194320190376519432

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth20Millimeter
Width25Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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