FDA.reportPublic FDA data

Nakoma

Primary DI
M6863100T18040
Brand
Nakoma
Company
ALLIANCE PARTNERS LLC
Model
3100T-1804
Catalog number
3100T-1804
Device description
Drill Bit Instrument
Published
2016-09-23
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141993000NAKOMA ACPAlliance Partners, LLC2014-11-06KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6863100T18040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusable"A 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."

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter
Outer Diameter2.3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(210)314-2525info@alliance-spine.com

Regulatory Flags#

DUNS number
962768169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6861412T3000Alamo C1412T-3001412T-3002016-09-23
M6862100T19010Alamo P, Alamo T2100T-19012100T-19012017-01-01
M6862100T19020Alamo P, Alamo T2100T-19022100T-19022017-01-01
M6863100T12000Nakoma3100T-12003100T-12002016-09-23
M6863100I10000Nakoma-SL ACP System3100I-10003100I-10002015-09-14
M6863100I10010Nakoma-SL ACP System3100I-10013100I-10012015-09-14
M6863100I10020Nakoma-SL ACP System3100I-10023100I-10022015-09-14
M6863100I10030Nakoma-SL ACP System3100I-10033100I-10032015-09-14
M6863100I10040Nakoma-SL ACP System3100I-10043100I-10042015-09-14
M6863100I10050Nakoma-SL ACP System3100I-10053100I-10052015-09-14
M6863100I10060Nakoma-SL ACP System3100I-10063100I-10062015-09-14
M6863100I20000Nakoma-SL ACP System3100I-20003100I-20002015-09-14
M6863100I20010Nakoma-SL ACP System3100I-20013100I-20012015-09-14
M6863100I20020Nakoma-SL ACP System3100I-20023100I-20022015-09-14
M6863100I20030Nakoma-SL ACP System3100I-20033100I-20032015-09-14
M6863100I20040Nakoma-SL ACP System3100I-20043100I-20042015-09-14
M6863100I20050Nakoma-SL ACP System3100I-20053100I-20052015-09-14
M6863100I20060Nakoma-SL ACP System3100I-20063100I-20062015-09-14
M6863100I20070Nakoma-SL ACP System3100I-20073100I-20072015-09-14
M6863100I20080Nakoma-SL ACP System3100I-20083100I-20082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544403InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544434InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544441InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544458InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544465InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544489InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544861InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544878InvictusALPHATEC SPINE, INC.HTW2026-07-30
03701089515153AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089526579AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528047AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528344AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528351AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089529976AMPLITUDEAMPLITUDE SASHTW2026-07-29
03700569674359Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569674366Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569674700Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569679194Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569680220Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
03700569680237Newclip InstrumentsNEWCLIP TECHNICSHTW2026-07-28
00810135961264ToejackNVision Biomedical Technologies, Inc.HTW2026-07-24
00889024709188DISTAL GRADUATED DRILL SHORTBiomet Orthopedics, LLCHTW2026-07-24
18059015378306Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
18059015378313Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
B803SYN31005100ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310230ORTHOMEDORTHO-MED, INC.HTW2026-07-22