CONTACT® ALP Anterior Lumbar Plate System 25-65-32

GUDID 00846468028589

6.5 x 32 RESCUE SCREW ASSEMBLY

Pioneer Surgical Technology, 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 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 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 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 Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

Primary Device ID	00846468028589
NIH Device Record Key	c1f25bc5-57e5-44bc-9e51-060c1ac9df34
Commercial Distribution Status	In Commercial Distribution
Brand Name	CONTACT® ALP Anterior Lumbar Plate System
Version Model Number	25-65-32
Catalog Number	25-65-32
Company DUNS	793384496
Company Name	Pioneer Surgical Technology, Inc.
Device Count	1
DM Exempt	false
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

Customer Support Contacts

Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com
Phone	+1(386)418-8888
Email	labeling@rtix.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468028589 [Primary]
GS1	00846468091699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090222

FDA Product Code

KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY