151-14-17

GUDID 10885862030061

PILOT SHAFT, MILL GUIDE, METAPHYSEAL, 17mm x 165mm

Exactech, Inc.

Orthopaedic reamer guide

Primary Device ID	10885862030061
NIH Device Record Key	f6a62d08-d840-40a4-ad52-44c32130fe7d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	151-14-17
Catalog Number	151-14-17
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

Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Length	165 Millimeter
Outer Diameter	17 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862030061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K010120

FDA Product Code

JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented