FDA.reportPublic FDA data

Nakoma

Primary DI
M6863100T23000
Brand
Nakoma
Company
ALLIANCE PARTNERS LLC
Model
3100T-2300
Catalog number
3100T-2300
Device description
Screw Removal Tool 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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

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
M6863100T23000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21