FDA.reportPublic FDA data

AVATAR Minimally Invasive Spinal System Instruments

Primary DI
00190837171889
Brand
AVATAR Minimally Invasive Spinal System Instruments
Company
Life Spine, Inc.
Model
116-002
Published
2025-07-07
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
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111953000NAUTILUS SPINAL SYSTEMLife Spine2012-08-07NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837171889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837171889001908371718891908371718890190837171889

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183641617
Device count
1
Lot or batch
true
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
00190837030957Pro Lift Instruments151-219151-2192019-11-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157120962ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120979ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120986ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120993ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121006ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121013ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121020ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121037ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121044ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121051ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121068ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121075ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121082ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121099ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121105ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121112ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121129ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121136ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121143ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121150ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121167ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121174ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121181ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121198ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121204ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121211ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121228ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121235ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121242ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121259ZAVATION SCREWZavation LLCNKB2026-10-15