Dakota ACDF System 71-DV-4015

GUDID 00840019941150

ø4.0 x 15mm Self-Drilling Screw

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable

Primary Device ID	00840019941150
NIH Device Record Key	072b6ec4-371d-4b30-85ba-318fe5059aab
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dakota ACDF System
Version Model Number	71-DV-4015
Catalog Number	71-DV-4015
Company DUNS	079398589
Company Name	PRECISION SPINE, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019941150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203129

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

[00840019941150]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-06-14
Device Publish Date	2021-06-04

On-Brand Devices [Dakota ACDF System]

00840019941273	ø4.0 x 18mm Self-Tapping Screw
00840019941266	ø4.0 x 17mm Self-Tapping Screw
00840019941259	ø4.0 x 15mm Self-TappingScrew
00840019941242	ø4.0 x 14mm Self-Tapping Screw
00840019941235	ø4.0 x 12mm Self-Tapping Screw
00840019941228	ø3.5 x 18mm Self-Tapping Screw
00840019941211	ø3.5 x 17mm Self-Tapping Screw
00840019941204	ø3.5 x 15mm Self-Tapping Screw
00840019941198	ø3.5 x 14mm Self-Tapping Screw
00840019941181	ø3.5 x 12mm Self-Tapping Screw
00840019941174	ø4.0 x 18mm Self-Drilling Screw
00840019941167	ø4.0 x 17mm Self-Drilling Screw
00840019941150	ø4.0 x 15mm Self-Drilling Screw
00840019941143	ø4.0 x 14mm Self-Drilling Screw
00840019941136	ø4.0 x 12mm Self-Drilling Screw
00840019941129	ø3.5 x 18mm Self-Drilling Screw
00840019941112	ø3.5 x 17mm Self-Drilling Screw
00840019941105	ø3.5 x 15mm Self-Drilling Screw
00840019941099	ø3.5 x 14mm Self-Drilling Screw
00840019941082	ø3.5 x 12mm Self-Drilling Screw
00840019941914	Screw Tap - 14mm
00840019941907	Screw Tap - 12mm
00840019941846	Angled Awl
00840019941785	Drill Guide
00840019941778	Straight Awl
00840019941754	Rasp, 7° Lordosis, 18x15 - 11/12mm
00840019941747	Rasp, 7° Lordosis, 18x15 - 9/10mm
00840019941730	Rasp, 7° Lordosis, 18x15 - 7/8mm
00840019941723	Rasp, 7° Lordosis, 18x15 - 5/6mm
00840019941716	Rasp, 7° Lordosis, 16x14 - 11/12mm
00840019941709	Rasp, 7° Lordosis, 16x14 - 9/10mm
00840019941693	Rasp, 7° Lordosis, 16x14 - 7/8mm
00840019941686	Rasp, 7° Lordosis, 16x14 - 6mm
00840019941679	Rasp, 7° Lordosis, 14x12 - 11/12mm
00840019941662	Rasp, 7° Lordosis, 14x12 - 9/10mm
00840019941655	Rasp, 7° Lordosis, 14x12 - 7/8mm
00840019941648	Rasp, 7° Lordosis, 14x12 - 5/6mm
00840019941631	Rasp, 0° Lordosis, 18x15 - 11/12mm
00840019941624	Rasp, 0° Lordosis, 18x15 - 9/10mm
00840019941617	Rasp, 0° Lordosis, 18x15 - 7/8mm
00840019941600	Rasp, 0° Lordosis, 18x15 - 5/6mm
00840019941594	Rasp, 0° Lordosis, 16x14 - 11/12mm
00840019941587	Rasp, 0° Lordosis, 16x14 - 9/10mm
00840019941570	Rasp, 0° Lordosis, 16x14 - 7/8mm
00840019941563	Rasp, 0° Lordosis, 16x14 - 6mm
00840019941556	Rasp, 0° Lordosis, 14x12 - 11/12mm
00840019941549	Rasp, 0° Lordosis, 14x12 - 9/10mm
00840019941532	Rasp, 0° Lordosis, 14x12 - 7/8mm
00840019941525	Rasp, 0° Lordosis, 14x12 - 5/6mm
00840019941518	Trial, 7° Lordosis, 18x15 - 11/12mm

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