151-14-10

GUDID 10885862030016

PILOT SHAFT, MILL GUIDE, METAPHYSEAL, 9mm x 165mm

Exactech, Inc.

Orthopaedic reamer guide

Primary Device ID	10885862030016
NIH Device Record Key	5b14f2d1-ea42-4927-bf22-4ef9e884f7be
Commercial Distribution Status	In Commercial Distribution
Version Model Number	151-14-10
Catalog Number	151-14-10
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
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0
Length	165 Millimeter
Device Size Text, specify	0
Outer Diameter	9 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862030016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K010120

FDA Product Code

LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED