Slimplicity Anterior Cervical Plate System 08-5018f

GUDID 00815362021538

Fixed Rescue Screw 18mm

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable

Primary Device ID	00815362021538
NIH Device Record Key	09230957-03be-438d-861a-2af1f4f83e0e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Slimplicity Anterior Cervical Plate System
Version Model Number	08-5018f
Catalog Number	08-5018f
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	false
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	00815362021538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112748

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

[00815362021538]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-04-09
Device Publish Date	2019-04-01

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