FDA.reportPublic FDA data

Reform® Ti CT Modular MIS Pedicle Screw System

Primary DI
00840019967655
Brand
Reform® Ti CT Modular MIS Pedicle Screw System
Company
PRECISION SPINE, INC.
Model
64-RD-2800
Catalog number
64-RD-2800
Device description
Tulip Manipulator, Open / Closed
Published
2023-08-07
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
LHXTrousers, Anti-Shock

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHXTrousers, Anti-ShockCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019967655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019967655008400199676558400199676550840019967655

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
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
00840019970907MD-Vue™ Lateral Access System54-TA-050054-TA-05002026-05-01
00840019970914MD-Vue™ Lateral Access System54-TA-060054-TA-06002026-05-01
00840019970921MD-Vue™ Lateral Access System54-TA-070054-TA-07002026-05-01
00840019970938MD-Vue™ Lateral Access System54-TA-080054-TA-08002026-05-01
00840019970945MD-Vue™ Lateral Access System54-TA-090054-TA-09002026-05-01
00840019970952MD-Vue™ Lateral Access System54-TA-100054-TA-10002026-05-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089589ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00198506089596ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00885556919620R3Smith & Nephew, Inc.LHX2024-11-06
00885556919613R3Smith & Nephew, Inc.LHX2024-11-04
00191083047300AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047317AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047324AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047331AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047348AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047355AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047362AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047379AlloWedgeRti Surgical, Inc.LHX2024-10-14
00840343722876GEN2SURGIX MEDICAL LLCLHX2024-06-28
08800017205267LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
08800068981486LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
00840343720537GEN2SURGIX MEDICAL LLCLHX2023-12-15
00840343720957GEN2SURGIX MEDICAL LLCLHX2023-12-15
10889981321390SpecialsSeaspine Orthopedics CorporationLHX2023-12-06
00840343719326Gen2SURGIX MEDICAL LLCLHX2023-11-14
00840343719364Gen2SURGIX MEDICAL LLCLHX2023-11-14
00885556910757LegionSmith & Nephew, Inc.LHX2023-09-06
00885556832417Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LHX2023-08-02
10889981308315SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308322SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308339SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308346SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308353SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308438SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
00850005827337GENESIS AWL/TAPPERGenesis Biologics, Inc.LHX2023-03-16
00885556850794Cadence Total Ankle SystemSmith & Nephew, Inc.LHX2023-02-02