FDA.reportPublic FDA data

ProAM ALIF System

Primary DI
00810152902325
Brand
ProAM ALIF System
Company
Pro Surgical, Inc.
Model
LN-014229-0620
Catalog number
LN-014229-0620
Device description
ALIF Trial - 42mm x 29mm x 20mm, 6°
Published
2025-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152902325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152902325008101529023258101529023250810152902325

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119149675
Device count
1
Premarket 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09