FDA.reportPublic FDA data

ProAM ALIF System

Primary DI
00810152902523
Brand
ProAM ALIF System
Company
Pro Surgical, Inc.
Model
LN-010555-0000
Catalog number
LN-010555-0000
Device description
Awl - Straight
Published
2025-02-12
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
00810152902523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152902523008101529025238101529025230810152902523

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. 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

Other Devices Sharing Product Codes#

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