Nakoma ACP System 3100I-6501

GUDID M6863100I65010

Cervical Plating System 4.5x13mm Fixed Self-Tapping Screw

ALLIANCE PARTNERS LLC

Spinal fixation plate, non-bioabsorbable
Primary Device IDM6863100I65010
NIH Device Record Key629a42f7-b979-4676-9ac0-7c2e4248202f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNakoma ACP System
Version Model Number3100I-6501
Catalog Number3100I-6501
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

Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter
Outer Diameter4.5 Millimeter
Length13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM6863100I65010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

Moist Heat or Steam Sterilization

[M6863100I65010]

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 ACP System]

M6863100I95080Cervical Plating System 4.5x20mm Fixed Self-Drilling Screw
M6863100I95070Cervical Plating System 4.5x19mm Fixed Self-Drilling Screw
M6863100I95060Cervical Plating System 4.5x18mm Fixed Self-Drilling Screw
M6863100I95050Cervical Plating System 4.5x17mm Fixed Self-Drilling Screw
M6863100I95040Cervical Plating System 4.5x16mm Fixed Self-Drilling Screw
M6863100I95030Cervical Plating System 4.5x15mm Fixed Self-Drilling Screw
M6863100I95020Cervical Plating System 4.5x14mm Fixed Self-Drilling Screw
M6863100I95010Cervical Plating System 4.5x13mm Fixed Self-Drilling Screw
M6863100I95000Cervical Plating System 4.5x12mm Fixed Self-Drilling Screw
M6863100I90100Cervical Plating System 4.0x20mm Fixed Self-Drilling Screw
M6863100I90090Cervical Plating System 4.0x19mm Fixed Self-Drilling Screw
M6863100I90080Cervical Plating System 4.0x18mm Fixed Self-Drilling Screw
M6863100I90070Cervical Plating System 4.0x17mm Fixed Self-Drilling Screw
M6863100I90060Cervical Plating System 4.0x16mm Fixed Self-Drilling Screw
M6863100I90050Cervical Plating System 4.0x15mm Fixed Self-Drilling Screw
M6863100I90040Cervical Plating System 4.0x14mm Fixed Self-Drilling Screw
M6863100I90030Cervical Plating System 4.0x13mm Fixed Self-Drilling Screw
M6863100I90020Cervical Plating System 4.0x12mm Fixed Self-Drilling Screw
M6863100I90010Cervical Plating System 4.0x11mm Fixed Self-Drilling Screw
M6863100I90000Cervical Plating System 4.0x10mm Fixed Self-Drilling Screw
M6863100I85080Cervical Plating System 4.5x20mm Variable Self-Tapping Screw
M6863100I85070Cervical Plating System 4.5x19mm Variable Self-Tapping Screw
M6863100I85060Cervical Plating System 4.5x18mm Variable Self-Tapping Screw
M6863100I85050Cervical Plating System 4.5x17mm Variable Self-Tapping Screw
M6863100I85040Cervical Plating System 4.5x16mm Variable Self-Tapping Screw
M6863100I85030Cervical Plating System 4.5x15mm Variable Self-Tapping Screw
M6863100I85020Cervical Plating System 4.5x14mm Variable Self-Tapping Screw
M6863100I85010Cervical Plating System 4.5x13mm Variable Self-Tapping Screw
M6863100I85000Cervical Plating System 4.5x12mm Variable Self-Tapping Screw
M6863100I80100Cervical Plating System 4.0x20mm Variable Self-Tapping Screw
M6863100I80090Cervical Plating System 4.0x19mm Variable Self-Tapping Screw
M6863100I80080Cervical Plating System 4.0x18mm Variable Self-Tapping Screw
M6863100I80070Cervical Plating System 4.0x17mm Variable Self-Tapping Screw
M6863100I80060Cervical Plating System 4.0x16mm Variable Self-Tapping Screw
M6863100I80050Cervical Plating System 4.0x15mm Variable Self-Tapping Screw
M6863100I80040Cervical Plating System 4.0x14mm Variable Self-Tapping Screw
M6863100I80030Cervical Plating System 4.0x13mm Variable Self-Tapping Screw
M6863100I80020Cervical Plating System 4.0x12mm Variable Self-Tapping Screw
M6863100I80010Cervical Plating System 4.0x11mm Variable Self-Tapping Screw
M6863100I80000Cervical Plating System 4.0x10mm Variable Self-Tapping Screw
M6863100I75080Cervical Plating System 4.5x20mm Variable Self-Drilling Screw
M6863100I75070Cervical Plating System 4.5x19mm Variable Self-Drilling Screw
M6863100I75060Cervical Plating System 4.5x18mm Variable Self-Drilling Screw
M6863100I75050Cervical Plating System 4.5x17mm Variable Self-Drilling Screw
M6863100I75040Cervical Plating System 4.5x16mm Variable Self-Drilling Screw
M6863100I75030Cervical Plating System 4.5x15mm Variable Self-Drilling Screw
M6863100I75020Cervical Plating System 4.5x14mm Variable Self-Drilling Screw
M6863100I75010Cervical Plating System 4.5x13mm Variable Self-Drilling Screw
M6863100I75000Cervical Plating System 4.5x12mm Variable Self-Drilling Screw
M6863100I70100Cervical Plating System 4.0x20mm Variable Self-Drilling Screw
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