213-60-02

GUDID 10885862059604

HEAD, PATELLA DRILL GUIDE, LPI, 26mm

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

Primary Device ID	10885862059604
NIH Device Record Key	65c7d861-cb28-4b36-a094-5348f7f04a7e
Commercial Distribution Status	In Commercial Distribution
Version Model Number	213-60-02
Catalog Number	213-60-02
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 Dimensions

Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter
Lumen/Inner Diameter	26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862059604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K932690

FDA Product Code

JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER