JAWS Staple System P70-921-0810

GUDID 00889795049810

JAWS Trial Sizer 8mm and 10mm

PARAGON 28, INC.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

Primary Device ID	00889795049810
NIH Device Record Key	64c7a719-3b7e-42c3-b4b2-64276cc95019
Commercial Distribution Status	In Commercial Distribution
Brand Name	JAWS Staple System
Version Model Number	P70-921-0810
Catalog Number	P70-921-0810
Company DUNS	042961576
Company Name	PARAGON 28, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795049810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170923

FDA Product Code

JDR	Staple, fixation, bone