FDA.reportPublic FDA data

Nakoma

Primary DI
M6863100T11000
Brand
Nakoma
Company
ALLIANCE PARTNERS LLC
Model
3100T-1100
Catalog number
3100T-1100
Device description
Plate Holder 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
M6863100T11000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). 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
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03