FDA.reportPublic FDA data

Pro Lift Instruments

Primary DI
00190837030957
Brand
Pro Lift Instruments
Company
Life Spine, Inc.
Model
151-219
Catalog number
151-219
Published
2019-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173182000ProLift® Expandable SystemLife Spine, Inc.2017-12-20MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837030957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837030957001908370309571908370309570190837030957

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183641617
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190837085728ProLift Lateral149-4002149-40022019-11-19
00190837030919Pro Lift Instruments114-204-2114-204-22019-11-07
00190837030926Pro Lift Instruments114-204-3114-204-32019-11-07
00190837030964Pro Lift Instruments112-222112-2222019-11-07
00190837030988Pro Lift Instruments112-351112-3512019-11-07
00190837030995Pro Lift Instruments129-1006129-10062019-11-07
00190837031008Pro Lift Instruments129-1007129-10072019-11-07
00190837031015Pro Lift Instruments129-1008129-10082019-11-07
00190837031022Pro Lift Instruments129-1009129-10092019-11-07
00190837031039Pro Lift Instruments129-1010129-10102019-11-07
00190837031046Pro Lift Instruments129-1011129-10112019-11-07
00190837031053Pro Lift Instruments129-1012129-10122019-11-07
00190837031060Pro Lift Instruments129-1013129-10132019-11-07
00190837031077Pro Lift Instruments151-262151-2622019-11-07
00190837031084Pro Lift Instruments151-265151-2652019-11-07
00190837031091Pro Lift Instruments151-268151-2682019-11-07
00190837031107Pro Lift Instruments151-271151-2712019-11-07
00190837031121Pro Lift Instruments151-277151-2772019-11-07
00190837031138Pro Lift Instruments151-280151-2802019-11-07
00190837031145Pro Lift Instruments151-283151-2832019-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161900817EARP, 22X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900824EARP, 22X40X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900831EARP, 22X45X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900848EARP, 22X45X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900855EARP, 22X45X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900862EARP, 22X45X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900879EARP, 22X45X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901265EARP, 22X50X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901272EARP, 22X50X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901289EARP, 22X50X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901296EARP, 22X50X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901302EARP, 22X50X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520094ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520179ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10