FDA.report

Reform Ti Modular

Primary DI
00840019973052
Brand
Reform Ti Modular
Company
PRECISION SPINE, INC.
Model
73-BK-0103
Catalog number
73-BK-0103
Device description
Reform® MAX Modular Driver BOM (GLOBOT)
Published
2025-03-05
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

Related Records

Product Codes

CodeName
GADRetractor

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840019973052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019973052008400199730528400199730520840019973052

GMDN Terms

TermDefinition
Neurosurgical retraction system, spinalA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of dorsal tissue to enable access for spinal surgery. It includes a mounting frame, with retracting blades which may come together to form a tube-like port; it may be intended to attach to a fixed arm, e.g., an arm attached to the surgical table. This is a reusable device.

Sterilization Methods

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
true
Serial number
false
Manufacturing date on label
true
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 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 DIBrandCompanyProduct codePublished
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
00198506089695ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-20
00199150062263Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062270Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062287Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00840277133427Innomed, Inc.INNOMED, INC.GAD2026-03-20
00198506055393ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-19
10885862648587EquinoxeExactech, Inc.GAD2026-03-19
10885862648594EquinoxeExactech, Inc.GAD2026-03-19
10885862661234N/AExactech, Inc.GAD2026-03-19
10885862661371NovationExactech, Inc.GAD2026-03-19
10885862661388NovationExactech, Inc.GAD2026-03-19
10885862661395NovationExactech, Inc.GAD2026-03-19
10885862661401NovationExactech, Inc.GAD2026-03-19
00198506089671ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00198506089688ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00810123209996Adler Instrument CompanyAdler, Inc.GAD2026-03-17
00810220800027Adler Instrument CompanyAdler, Inc.GAD2026-03-17
20763000284897OctoBase™MEDTRONIC, INC.GAD2026-03-14
00841536147766ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147773ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147780ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00810158219298PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
00810158219342PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
M93074301120S0Life InstrumentsLife Instrument CorporationGAD2026-03-12