FDA.reportPublic FDA data

Screw Dispenser Kit

Primary DI
M209171490
Brand
Screw Dispenser Kit
Company
BIOPRO, INC.
Model
17149
Published
2019-05-01
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
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963433000THREADED FIXATION PINOrthopaedic Biosystems, Ltd.1996-11-06JDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209171490PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209101790ENDO MD 38101792015-09-16
M209101800ENDO MD 41101802015-09-16
M209101820ENDO MD 45101822015-09-16
M209101830ENDO MD 47101832015-09-16
M209101840ENDO MD 49101842015-09-16
M209101850ENDO MD 51101852015-09-16
M209101860ENDO MD 53101862015-09-16
M209101870ENDO MD 55101872015-09-16
M209101880ENDO SH 38101882015-09-16
M209101890ENDO SH 41101892015-09-16
M209101900ENDO SH 43101902015-09-16
M209101910ENDO SH 45101912015-09-16
M209101920ENDO SH 47101922015-09-16
M209101930ENDO SH 49101932015-09-16
M209101940ENDO SH 51101942015-09-16
M209101950ENDO SH 53101952015-09-16
M209101960ENDO SH 55101962015-09-16
M209130070ENDO MODULAR CERAMIC SH 41130072015-09-16
M209130080ENDO MODULAR CERAMIC SH 43130082015-09-16
M209130090ENDO MODULAR CERAMIC SH 45130092015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800308486047INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.HXX2026-11-04
08800308486054INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.HXX2026-11-04
00841731133717REDEMPTION Beaming SystemVILEX LLCHXX2026-11-03
00841731133724REDEMPTION Beaming SystemVILEX LLCHXX2026-11-03
08800322759233Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08800322759240Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809695602887Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809974815953Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809974816004Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
B382SD91449311010Surgical DirectSurgical Direct, Inc.HXX2026-10-28
08800089487820Surgical InstrumentJeil Medical CorporationHXX2026-10-26
00190776436933MillenniumAvalign Technologies, Inc.HXX2026-10-23
09120125220242Shark Screw® driver cutsurgebright GmbHHXX2026-10-22
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00824846013600Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HXX2026-10-19
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08