FDA.reportPublic FDA data

T-Handle Cann Hud-Mod

Primary DI
00810097801189
Brand
T-Handle Cann Hud-Mod
Company
Osteocentric Technologies, Inc.
Model
202-0802
Catalog number
202-0802
Device description
T-Handle Cann Hud-Mod
Published
2022-08-16
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
K230226000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230226000Integrity-SI® Fusion SystemOsteoCentric Technologies2023-09-21OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810097801189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097801189008100978011898100978011890810097801189

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of non-sterile surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. 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
00841732162792VALEOCTL Medical CorporationHXX2024-10-02
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
00818069019631TecometTECOMET INC.HXX2020-10-09
00818069019655TecometTECOMET INC.HXX2020-10-09
00818069019662TecometTECOMET INC.HXX2020-10-09
00818069019679TecometTECOMET INC.HXX2020-10-09
00818069019839TecometTECOMET INC.HXX2020-10-09
00818069019969TecometTECOMET INC.HXX2020-10-09