FDA.reportPublic FDA data

ProAM ALIF System

Primary DI
00810152902455
Brand
ProAM ALIF System
Company
Pro Surgical, Inc.
Model
LN-010501-0000
Catalog number
LN-010501-0000
Device description
ALIF Straight Inserter
Published
2025-02-12
Public version status
Update
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
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
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
00810152902455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152902455008101529024558101529024550810152902455

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119149675
Device count
1
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
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
00810152900239ProAM ALIF SystemLN-033425-2420LN-033425-24202025-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03