FDA.reportPublic FDA data

13.0mm Tap Cannulated

Primary DI
00816950029424
Brand
13.0mm Tap Cannulated
Company
Osteocentric Technologies, Inc.
Model
317-0011
Catalog number
317-0011
Device description
13.0mm Tap Cannulated
Published
2021-05-07
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
HWXTap, Bone
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210247000OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021-04-30JDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816950029424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816950029424008169500294248169500294240816950029424

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter13Millimeter

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
07640450868374PERLA ®SpineArt SAHWX2025-11-10
07640450868381PERLA ®SpineArt SAHWX2025-11-10
08800308480564INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480571INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480588INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480595INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480601INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
008101182100063.7mm TapOsteocentric Technologies, Inc.HWX2023-10-30
008101182100134.2mm TapOsteocentric Technologies, Inc.HWX2023-10-30
008101182100205.5mm TapOsteocentric Technologies, Inc.HWX2023-10-30
07640177820464Neo Medical Pedicle Screw SystemNeo Medical SAHWX2023-01-25
07640177820471Neo Medical Pedicle Screw SystemNeo Medical SAHWX2023-01-25
07640177820488Neo Medical Pedicle Screw SystemNeo Medical SAHWX2023-01-25
07640177821119Neo Medical Pedicle Screw SystemNeo Medical SAHWX2023-01-25
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08052990974535DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739536225ST.A.R. 90 F4CITIEFFE SRLKTT2019-11-29
00841732124660GENERIC Surgical InstrumentsCTL Medical CorporationHWX2019-10-18
00841732124677GENERIC Surgical InstrumentsCTL Medical CorporationHWX2019-10-18