FDA.reportPublic FDA data

Ascend

Primary DI
00190376517964
Brand
Ascend
Company
ALPHATEC SPINE, INC.
Model
156-12-250
Device description
CV VBR 12 mm Expansion Driver Long
Published
2024-10-28
Public version status
Update
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
00190376517964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376517964001903765179641903765179640190376517964

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable 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
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