FDA.reportPublic FDA data

ProAM ALIF System

Primary DI
00810152900871
Brand
ProAM ALIF System
Company
Pro Surgical, Inc.
Model
LN-034229-3016
Catalog number
LN-034229-3016
Device description
Fixated ALIF 3-Hole - 42mm x 29mm x 16mm, 30°
Published
2025-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240126000ProAM ALIF SystemPro Surgical, Inc.2024-05-03OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152900871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152900871008101529008718101529008710810152900871

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119149675
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152902455ProAM ALIF SystemLN-010501-0000LN-010501-00002025-02-12
00810152900048ProAM ALIF SystemLN-033425-0618LN-033425-06182025-01-16
00810152900055ProAM ALIF SystemLN-033425-0620LN-033425-06202025-01-16
00810152900062ProAM ALIF SystemLN-033425-1210LN-033425-12102025-01-16
00810152900079ProAM ALIF SystemLN-033425-1212LN-033425-12122025-01-16
00810152900086ProAM ALIF SystemLN-033425-1214LN-033425-12142025-01-16
00810152900093ProAM ALIF SystemLN-033425-1216LN-033425-12162025-01-16
00810152900109ProAM ALIF SystemLN-033425-1218LN-033425-12182025-01-16
00810152900116ProAM ALIF SystemLN-033425-1220LN-033425-12202025-01-16
00810152900123ProAM ALIF SystemLN-033425-1810LN-033425-18102025-01-16
00810152900130ProAM ALIF SystemLN-033425-1812LN-033425-18122025-01-16
00810152900147ProAM ALIF SystemLN-033425-1814LN-033425-18142025-01-16
00810152900154ProAM ALIF SystemLN-033425-1816LN-033425-18162025-01-16
00810152900161ProAM ALIF SystemLN-033425-1818LN-033425-18182025-01-16
00810152900178ProAM ALIF SystemLN-033425-1820LN-033425-18202025-01-16
00810152900185ProAM ALIF SystemLN-033425-2410LN-033425-24102025-01-16
00810152900192ProAM ALIF SystemLN-033425-2412LN-033425-24122025-01-16
00810152900208ProAM ALIF SystemLN-033425-2414LN-033425-24142025-01-16
00810152900215ProAM ALIF SystemLN-033425-2416LN-033425-24162025-01-16
00810152900222ProAM ALIF SystemLN-033425-2418LN-033425-24182025-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075989ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157075996ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076009ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076016ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076023ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076030ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076047ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076054ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076061ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
07613153046196AVS PLStryker CorporationOVD2015-09-14
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationOVD2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationOVD2015-09-14
07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14