Equinoxe 315-28-13

GUDID 10885862200372

CENTER PEG DRILL GUIDE POST- AUG, RIGHT, 12 DEG

Exactech, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

Primary Device ID	10885862200372
NIH Device Record Key	70d0e22e-9161-49c3-bec1-1cb38431ca58
Commercial Distribution Status	In Commercial Distribution
Brand Name	Equinoxe
Version Model Number	315-28-13
Catalog Number	315-28-13
Company DUNS	157565946
Company Name	Exactech, 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	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	10885862200372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K103419

FDA Product Code

KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED