WORKHORSE SCREW, T10, NON-LOCKING 3.5mm x 16mm

GUDID 00848665036992

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

Primary Device ID	00848665036992
NIH Device Record Key	13fc72f5-adc1-47e3-b211-23eeecd8160e
Commercial Distribution Status	In Commercial Distribution
Brand Name	WORKHORSE SCREW, T10, NON-LOCKING 3.5mm x 16mm
Version Model Number	8100-018
Company DUNS	117858154
Company Name	ADVANCED ORTHOPEDIC SOLUTIONS 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	true
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	3105339966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com
Phone	(310) 533-9966
Email	regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665036992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152732
Premarket Notification: K161913

FDA Product Code

HRS	Plate, Fixation, Bone
HWC	Screw, Fixation, Bone