Minima Hip 9045.03.070

GUDID 08033390090803

Broach #7

LIMACORPORATE SPA

Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable

Primary Device ID	08033390090803
NIH Device Record Key	b53c495c-7b83-49f2-8769-5406773b28e1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Minima Hip
Version Model Number	Broach
Catalog Number	9045.03.070
Company DUNS	432066322
Company Name	LIMACORPORATE SPA
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

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390090803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141327

FDA Product Code

LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented