FDA.reportPublic FDA data

Open T25 Super Locking Driver

Primary DI
00810097803480
Brand
Open T25 Super Locking Driver
Company
Osteocentric Technologies, Inc.
Model
101-0033
Catalog number
101-0033
Device description
Open T25 Super Locking Driver
Published
2024-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221332000OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies2022-07-28NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810097803480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097803480008100978034808100978034800810097803480

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags#

DUNS number
089645059
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100978037493.0mm GUIDE WIRE 355mm202-80600202-806002026-06-02
00810118210198Torque Wrench701-0019701-00192023-10-31
00810118210259.050 Driver, Short701-0025701-00252023-10-31
00810118210266.050 Driver, Long701-0026701-00262023-10-31
00810118210273.050 Driver, Latch701-0027701-00272023-10-31
00810118210280Thumb Knob701-0029701-00292023-10-31
00810118210327Latch Driver, 300 Series701-0033701-00332023-10-31
00810118210334Square Driver, 300 Series701-0034701-00342023-10-31
00810118210341Latch Driver, 400 Series701-0035701-00352023-10-31
00810118210358Square Driver, 400 Series701-0036701-00362023-10-31
00810118210365Ratchet Adapter701-0037701-00372023-10-31
008101182100063.7mm Tap701-0013701-00132023-10-30
008101182100134.2mm Tap701-0014701-00142023-10-30
008101182100205.5mm Tap701-0015701-00152023-10-30
00810118210129Drill Extender701-0009701-00092023-10-30
008101182101673.7mm Parallel Pin701-0016701-00162023-10-30
008101182101744.2mm Parallel Pin701-0017701-00172023-10-30
008101182101815.5mm Parallel Pin701-0018701-00182023-10-30
00810097803527NAV 3.5mm DRILL104-0003104-00032026-03-26
00810097803534NAV TAPERED PROBE104-0005104-00052026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732142312GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142428GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142435GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142442GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142459GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142466GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142473GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732143074GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732145078GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732160347GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-31
00841732142190GENERIC Surgical InstrumentsCTL Medical CorporationHXX2025-03-28
00841732166721GENERIC Surgical InstrumentsCTL Medical CorporationHXX2024-12-04
00841732166738GENERIC Surgical InstrumentsCTL Medical CorporationHXX2024-12-04
00810118210198Torque WrenchOsteocentric Technologies, Inc.HXX2023-10-31
00810118210259.050 Driver, ShortOsteocentric Technologies, Inc.HXX2023-10-31
00810118210266.050 Driver, LongOsteocentric Technologies, Inc.HXX2023-10-31
00810118210273.050 Driver, LatchOsteocentric Technologies, Inc.HXX2023-10-31
00810118210280Thumb KnobOsteocentric Technologies, Inc.HXX2023-10-31
00810118210327Latch Driver, 300 SeriesOsteocentric Technologies, Inc.HXX2023-10-31
00810118210334Square Driver, 300 SeriesOsteocentric Technologies, Inc.HXX2023-10-31
00810118210341Latch Driver, 400 SeriesOsteocentric Technologies, Inc.HXX2023-10-31
00810118210358Square Driver, 400 SeriesOsteocentric Technologies, Inc.HXX2023-10-31
00810118210365Ratchet AdapterOsteocentric Technologies, Inc.HXX2023-10-31
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