FDA.reportPublic FDA data

Arsenal

Primary DI
00190376003368
Brand
Arsenal
Company
ALPHATEC SPINE, INC.
Model
87779-35
Device description
3.5 mm Cannulated Drill, NI
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K153603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153603000Alphatec Navigation InstrumentsAlphatec Spine, Inc.2016-04-29OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376003368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376003368001903760033681903760033680190376003368

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376541471ATEC Lateral Navigation Disc Prep Instruments267-01-000-10-N2024-12-18
00190376529158ATEC Posterior Navigation Disc Prep Instruments244-01-000-06-N2024-04-20
00190376529189ATEC Posterior Navigation Disc Prep Instruments244-01-000-12-N2024-04-20
00190376476162ATEC Lateral Navigation Disc Prep Instruments266-01-000-08-N2023-08-26
00190376476179ATEC Lateral Navigation Disc Prep Instruments266-01-000-10-N2023-08-26
00190376476186ATEC Lateral Navigation Disc Prep Instruments266-01-000-12-N2023-08-26
00190376522906ATEC Lateral Navigation Disc Prep Instruments266-01-000-14-N2023-08-26
00840180512395General InstrumentsCI-11129-34242026-05-15
00840180543214General InstrumentsCI-118992026-05-15
00840180543542General InstrumentsCI-11915-302026-05-15
00840180544785General InstrumentsCI-11939-080-R2026-05-15
00840180544914General InstrumentsCI-11939-080-L2026-05-15
00840180545324General InstrumentsCI-11968-06-S2026-05-15
00840180545331General InstrumentsCI-11968-06-L2026-05-15
00840180545362General InstrumentsCI-11968-S2026-05-15
00840180545416General InstrumentsCI-11972-012026-05-15
00840180545423General InstrumentsCI-11972-032026-05-15
00840180545430General InstrumentsCI-11972-022026-05-15
00840180545447General InstrumentsCI-11972-042026-05-15
00840180545461General InstrumentsCI-11969-L2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13