DIAMOND WORKHORSE SCREW™, Ø3.5mm x 10mm

GUDID 00848665038200

ADVANCED ORTHOPAEDIC 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	00848665038200
NIH Device Record Key	b31aee17-49af-48ee-b389-66495ee10a8e
Commercial Distribution Status	In Commercial Distribution
Brand Name	DIAMOND WORKHORSE SCREW™, Ø3.5mm x 10mm
Version Model Number	8103-010
Company DUNS	117858154
Company Name	ADVANCED ORTHOPAEDIC 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	(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
Phone	(310) 533-9966
Email	regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665038200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K202489

FDA Product Code

HRS	Plate, Fixation, Bone