FDA.reportPublic FDA data

Ascend

Primary DI
00190376670522
Brand
Ascend
Company
ALPHATEC SPINE, INC.
Model
157-PRO-12L-224000-S
Device description
12mm CORE, NANOTEC LAT 22 x 40 mm 0°
Published
2025-10-21
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
MQPSpinal vertebral body replacement device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

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
00190376670522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376670522001903766705221903766705220190376670522

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
Length40Millimeter
Width22Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
602465783
Device count
1
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
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
00190376544502Invictus179222026-07-30
00190376544519Invictus179242026-07-30
00190376544861Invictus17920-112026-07-30
00190376544878Invictus17920-122026-07-30
00190376766133InvictusVMDCORT2026-07-30
00190376732008Segmental Plating System338-0214-S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888857461888CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
04546540389084VBOSSStryker CorporationMQP2015-09-14
04546540389091VBOSSStryker CorporationMQP2015-09-14
04546540389107VBOSSStryker CorporationMQP2015-09-14
04546540389114VBOSSStryker CorporationMQP2015-09-14
04546540389121VBOSSStryker CorporationMQP2015-09-14
04546540389138VBOSSStryker CorporationMQP2015-09-14
04546540389145VBOSSStryker CorporationMQP2015-09-14
04546540389152VBOSSStryker CorporationMQP2015-09-14
04546540389169VBOSSStryker CorporationMQP2015-09-14
04546540389176VBOSSStryker CorporationMQP2015-09-14
04546540389183VBOSSStryker CorporationMQP2015-09-14
04546540389190VBOSSStryker CorporationMQP2015-09-14
04546540389206VBOSSStryker CorporationMQP2015-09-14
04546540389213VBOSSStryker CorporationMQP2015-09-14
04546540389220VBOSSStryker CorporationMQP2015-09-14
04546540389237VBOSSStryker CorporationMQP2015-09-14
04546540389244VBOSSStryker CorporationMQP2015-09-14
04546540389251VBOSSStryker CorporationMQP2015-09-14
04546540389268VBOSSStryker CorporationMQP2015-09-14
04546540389275VBOSSStryker CorporationMQP2015-09-14
04546540389282VBOSSStryker CorporationMQP2015-09-14
04546540389299VBOSSStryker CorporationMQP2015-09-14
04546540389305VBOSSStryker CorporationMQP2015-09-14