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

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
00840019936798Sure-Lok Extended Tab Pedicle Screw System48-2000-CA48-2000-CA2019-09-03
00840019922661Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0004HXI-48-00042019-03-28
00840019922692Sure-Lok Extended Tab Pedicle Screw System48-200048-20002019-03-28
00840019922630Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0001HXI-48-00012019-03-27
00840019922647Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0002HXI-48-00022019-03-27
00840019922654Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0003HXI-48-00032019-03-27
00840019922678Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0005HXI-48-00052019-03-27
00840019922685Sure-Lok Extended Tab Pedicle Screw System48-110048-11002019-03-27
00840019925631PSS SystemHXI-SL-0001*HXI-SL-0001*2019-03-27
00840019978156Reform Ti39-TM-454539-TM-45452026-10-19
00840019978163Reform Ti39-TM-552039-TM-55202026-10-19
00840019978170Reform Ti39-TM-552539-TM-55252026-10-19
00840019978187Reform Ti39-TM-553039-TM-55302026-10-19
00840019978194Reform Ti39-TM-553539-TM-55352026-10-19
00840019978200Reform Ti39-TM-554039-TM-55402026-10-19
00840019978217Reform Ti39-TM-554539-TM-55452026-10-19
00840019978224Reform Ti39-TM-555039-TM-55502026-10-19
00840019978231Reform Ti39-TM-555539-TM-55552026-10-19
00840019978248Reform Ti39-TM-556039-TM-55602026-10-19
00840019978255Reform Ti39-TM-652539-TM-65252026-10-19

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