FDA.reportPublic FDA data

Intervertebral Body Fusion Device

Primary DI
00840019922241
Brand
Intervertebral Body Fusion Device
Company
PRECISION SPINE, INC.
Model
10-1008-2
Catalog number
10-1008-2
Device description
ALIF Cage Plate Universal Awl (10-1018 Handle)
Published
2019-03-27
Public version status
New
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
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019922241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019922241008400199222418400199222410840019922241

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00840019971133Reform Ti Modular39-SF-654539-SF-65452026-01-13
00840019971140Reform Ti Modular39-SF-655039-SF-65502026-01-13
00840019971157Reform Ti Modular39-SF-655539-SF-65552026-01-13
00840019971164Reform Ti Modular39-SF-656039-SF-65602026-01-13
00840019971171Reform Ti Modular39-SF-753039-SF-75302026-01-13
00840019971188Reform Ti Modular39-SF-753539-SF-75352026-01-13
00840019971195Reform Ti Modular39-SF-754039-SF-75402026-01-13
00840019971201Reform Ti Modular39-SF-754539-SF-75452026-01-13
00840019971218Reform Ti Modular39-SF-755039-SF-75502026-01-13
00840019971225Reform Ti Modular39-SF-755539-SF-75552026-01-13
00840019971232Reform Ti Modular39-SF-756039-SF-75602026-01-13
00840019971249Reform Ti Modular39-SF-757039-SF-75702026-01-13
00840019971256Reform Ti Modular39-SF-758039-SF-75802026-01-13
00840019971263Reform Ti Modular39-SF-853539-SF-85352026-01-13
00840019971270Reform Ti Modular39-SF-854039-SF-85402026-01-13
00840019971287Reform Ti Modular39-SF-854539-SF-85452026-01-13
00840019971294Reform Ti Modular39-SF-855039-SF-85502026-01-13
00840019971300Reform Ti Modular39-SF-855539-SF-85552026-01-13
00840019971317Reform Ti Modular39-SF-856039-SF-85602026-01-13
00840019971324Reform Ti Modular39-SF-857039-SF-85702026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536161775neon3Ulrich GmbH & Co. KGHWJ2026-05-26
00840311262854CONTACT ALPXtant Medical Holdings, Inc.HWJ2026-03-20
06974940306772endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306857endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306864endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306918endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
00199150066889Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-03-02
00190376709246AMP IIALPHATEC SPINE, INC.HWJ2026-02-18
00860015151322EnFix Instrument Kit - TACTETROUS, INC.HWJ2026-02-11
10886982361288NASynthes GmbHHWJ2026-02-11
00860014213427Awl - Non-CuttingTETROUS, INC.HWJ2026-02-10
00860014213434Cutting Awl - 5.5mmTETROUS, INC.HWJ2026-02-10
00860014213441Cutting Awl - 4.5mmTETROUS, INC.HWJ2026-02-10
00888480489818Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480489825Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480489832Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480597001Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480597018Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610847Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610861Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00888480610878Solitaire Cervical Spacer SystemHighridge Medical, LLCHWJ2025-12-29
00190376680422ProximityALPHATEC SPINE, INC.HWJ2025-12-19
10889981162252Vu a POD™ Prime NanoMetaleneSeaspine Orthopedics CorporationHWJ2025-12-19
10889981162269Vu a POD™ Prime NanoMetaleneSeaspine Orthopedics CorporationHWJ2025-12-19
03662663242929Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663242950Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243018Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243117Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243209Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18
03662663243216Alta ACDF SystemHighridge Medical, LLCHWJ2025-12-18