Nakoma-SL ACP System 3100I-2001

GUDID M6863100I20010

Cervical Plating System 2-Level 28mm Plate

ALLIANCE PARTNERS LLC

Spinal fixation plate, non-bioabsorbable
Primary Device IDM6863100I20010
NIH Device Record Key0713952f-f1f1-46cb-8fec-fa7803f62d9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNakoma-SL ACP System
Version Model Number3100I-2001
Catalog Number3100I-2001
Company DUNS962768169
Company NameALLIANCE PARTNERS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com
Phone+1(210)314-2525
Emailinfo@alliance-spine.com

Device Dimensions

Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM6863100I20010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

[M6863100I20010]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2015-09-14

On-Brand Devices [Nakoma-SL ACP System]

M6863100I50060Cervical Plating System 5-Level 105mm Plate
M6863100I50050Cervical Plating System 5-Level 100mm Plate
M6863100I50040Cervical Plating System 5-Level 95mm Plate
M6863100I50030Cervical Plating System 5-Level 90mm Plate
M6863100I50020Cervical Plating System 5-Level 85mm Plate
M6863100I50010Cervical Plating System 5-Level 80mm Plate
M6863100I50000Cervical Plating System 5-Level 75mm Plate
M6863100I40060Cervical Plating System 4-Level 84mm Plate
M6863100I40050Cervical Plating System 4-Level 80mm Plate
M6863100I40040Cervical Plating System 4-Level 76mm Plate
M6863100I40030Cervical Plating System 4-Level 72mm Plate
M6863100I40020Cervical Plating System 4-Level 68mm Plate
M6863100I40010Cervical Plating System 4-Level 64mm Plate
M6863100I40000Cervical Plating System 4-Level 60mm Plate
M6863100I30090Cervical Plating System 3-Level 67mm Plate
M6863100I30080Cervical Plating System 3-Level 64mm Plate
M6863100I30070Cervical Plating System 3-Level 61mm Plate
M6863100I30060Cervical Plating System 3-Level 58mm Plate
M6863100I30050Cervical Plating System 3-Level 55mm Plate
M6863100I30040Cervical Plating System 3-Level 52mm Plate
M6863100I30030Cervical Plating System 3-Level 49mm Plate
M6863100I30020Cervical Plating System 3-Level 46mm Plate
M6863100I30010Cervical Plating System 3-Level 43mm Plate
M6863100I30000Cervical Plating System 3-Level 40mm Plate
M6863100I20080Cervical Plating System 2-Level 46mm Plate
M6863100I20070Cervical Plating System 2-Level 43mm Plate
M6863100I20060Cervical Plating System 2-Level 40mm Plate
M6863100I20050Cervical Plating System 2-Level 37mm Plate
M6863100I20040Cervical Plating System 2-Level 34mm Plate
M6863100I20030Cervical Plating System 2-Level 32mm Plate
M6863100I20020Cervical Plating System 2-Level 30mm Plate
M6863100I20010Cervical Plating System 2-Level 28mm Plate
M6863100I20000Cervical Plating System 2-Level 26mm Plate
M6863100I10060Cervical Plating System 1-Level 24mm Plate
M6863100I10050Cervical Plating System 1-Level 22mm Plate
M6863100I10040Cervical Plating System 1-Level 20mm Plate
M6863100I10030Cervical Plating System 1-Level 18mm Plate
M6863100I10020Cervical Plating System 1-Level 16mm Plate
M6863100I10010Cervical Plating System 1-Level 14mm Plate
M6863100I10000Cervical Plating System 1-Level 12mm Plate
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