FDA.reportPublic FDA data

5.5 mm Cannulated Drill Bit, TORQ TNT, 375 mm

Primary DI
00810055523627
Brand
5.5 mm Cannulated Drill Bit, TORQ TNT, 375 mm
Company
Si-Bone Inc.
Model
501766-0375
Device description
5.5 mm Cannulated Drill Bit, TORQ TNT, 375 mm
Published
2024-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241504000iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.2024-08-19OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055523627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055523627008100555236278100555236270810055523627

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
855-884-3873info@si-bone.com

Regulatory Flags#

DUNS number
830127168
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00869397000013XL Instrument Set4000622026-03-24
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00869397000037Standard Instrument Set4000992026-03-24
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00810055525935Granite Point Lock Set Screw5031752025-08-25
00810055525867Driver Sleeve 2 Wrench Assembly4030432025-10-31
00810055525614BL Registration Tube - Broach5030942025-10-20
00810055525621BL Registration Tube - Impactor5030952025-10-20
00810055525638BL Adapter - Dovetail Mount4030022025-10-20
00810055524754iGPS 4.3mm Drill Bit5030422025-09-23
00810055524761iGPS 7.0mm Drill Bit502137-07002025-09-23
00810055524778iGPS 8.5mm Drill Bit502137-08502025-09-23
00810055524785iGPS 10.5mm Drill Bit502137-10502025-09-23
00810055524792Granite iGPS 8.5mm Awl Tip Tap502139-08502025-09-23
00810055524808Granite iGPS 9.0mm Awl Tip Tap502139-09002025-09-23
00810055524815Granite iGPS 9.5mm Awl Tip Tap502139-09502025-09-23
00810055524822Granite iGPS 10.0mm Awl Tip Tap502139-10002025-09-23
00810055524839Granite iGPS 10.5mm Awl Tip Tap502139-10502025-09-23

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