FDA.reportPublic FDA data

Reform MC Screw System

Primary DI
00840019927291
Brand
Reform MC Screw System
Company
PRECISION SPINE, INC.
Model
59-LB-1080
Catalog number
59-LB-1080
Device description
Single Level Blade, Left, 80mm
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019927291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019927291008400199272918400199272910840019927291

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
00198506091100ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00198506091117ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00810220800164Adler Instrument CompanyAdler, Inc.GAD2026-05-26
00199150071685Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071692Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071708Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071715Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071722Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071739Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071760Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071777Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071784Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071791Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071807Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071814Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150076444Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-23
00810143905779SURGIPROSSurgipros, LLCGAD2026-05-23
00810212930480SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930510SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930534SURGIPROSSurgipros, LLCGAD2026-05-22
M209232580Hintermann CompressorBIOPRO, INC.GAD2026-05-22
M209232590Hintermann DistractorBIOPRO, INC.GAD2026-05-22
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23