AccuFit RP System RPIF13-CP

GUDID 00840019912372

AccuFit ALIF RP Cover Plate 13mm

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

Primary Device ID	00840019912372
NIH Device Record Key	d9926507-28aa-4613-9277-d92adf942d18
Commercial Distribution Status	In Commercial Distribution
Brand Name	AccuFit RP System
Version Model Number	RPIF13-CP
Catalog Number	RPIF13-CP
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	00840019912372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092193

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body