FDA.reportPublic FDA data

Ascend

Primary DI
00190376521459
Brand
Ascend
Company
ALPHATEC SPINE, INC.
Model
153-16-B-184000-S
Device description
16 mm CORE ENDPLATE, BAN 18 x 40 mm 0°
Published
2023-12-22
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
MPQCONTAINER, SPECIMEN, URINE, DRUGS OF ABUSE, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The CounterPathology1

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
00190376521459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376521459001903765214591903765214590190376521459

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.

Sterilization Methods#

Method table
Method

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

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
00810185250028TherapakTherapak LLCMPQ2025-08-11
00810185250066TherapakTherapak LLCMPQ2025-08-11
00810185250080TherapakTherapak LLCMPQ2025-08-11
00810185250127TherapakTherapak LLCMPQ2025-08-11
00810185250141TherapakTherapak LLCMPQ2025-08-11
00810185250226TherapakTherapak LLCMPQ2025-08-11
00810185250240TherapakTherapak LLCMPQ2025-08-11
00810185250660TherapakTherapak LLCMPQ2025-08-11
00810185250035TherapakTherapak LLCMPQ2025-08-11
00810185250073TherapakTherapak LLCMPQ2025-08-11
00810185250097TherapakTherapak LLCMPQ2025-08-11
00810185250134TherapakTherapak LLCMPQ2025-08-11
00810185250158TherapakTherapak LLCMPQ2025-08-11
00810185250233TherapakTherapak LLCMPQ2025-08-11
00810185250257TherapakTherapak LLCMPQ2025-08-11
00810185250677TherapakTherapak LLCMPQ2025-08-11
00810185250103TherapakTherapak LLCMPQ2025-08-04
00810185250165TherapakTherapak LLCMPQ2025-08-04
00810185250264TherapakTherapak LLCMPQ2025-08-04
00810185250288TherapakTherapak LLCMPQ2025-08-04
00810185250301TherapakTherapak LLCMPQ2025-08-04
00810185250325TherapakTherapak LLCMPQ2025-08-04
00810185250585TherapakTherapak LLCMPQ2025-08-04
00810185250110TherapakTherapak LLCMPQ2025-08-04
00810185250172TherapakTherapak LLCMPQ2025-08-04
00810185250271TherapakTherapak LLCMPQ2025-08-04
00810185250295TherapakTherapak LLCMPQ2025-08-04
00810185250318TherapakTherapak LLCMPQ2025-08-04
00810185250332TherapakTherapak LLCMPQ2025-08-04
00810185250592TherapakTherapak LLCMPQ2025-08-04