MRH 6481-1-230

GUDID 07613327050080

MRH Knee Femoral Distal Block

Howmedica Osteonics Corp.

Rotating hinged total knee prosthesis

Primary Device ID	07613327050080
NIH Device Record Key	38aa7e9a-3f10-411a-8cfd-1acfa0727a2f
Commercial Distribution Status	In Commercial Distribution
Brand Name	MRH
Version Model Number	6481-1-230
Catalog Number	6481-1-230
Company DUNS	058311945
Company Name	Howmedica Osteonics Corp.
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	true
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327050080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223069
Premarket Notification: K994207

FDA Product Code

KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

On-Brand Devices [MRH]

07613327101089	Knee Tibial Baseplate
07613327101065	Knee Tibial Baseplate
07613327101058	Knee Tibial Baseplate
07613327101041	Knee Tibial Baseplate
07613327050097	MRH Knee Femoral Distal Block
07613327050080	MRH Knee Femoral Distal Block
07613327050073	MRH Knee Femoral Distal Block
07613327050066	MRH Knee Femoral Distal Block
07613327050059	MRH Knee Femoral Distal Block
07613327045376	MRH Knee Femoral Component
07613327045338	MRH Knee Tibial Baseplate
07613327045321	MRH Knee Tibial Baseplate
07613327045314	MRH Knee Tibial Baseplate
07613327045307	MRH Knee Tibial Baseplate
07613327045291	MRH Bushings, Sleeve, Neutral Bumper
07613327045284	MRH Knee Tibial Sleeve
07613327045277	MRH Knee Bumper Insert
07613327045260	MRH Knee Bumper Insert
07613327045253	Modular Rotating Hinge Knee-Axle
07613327045246	MRH Knee Femoral Bushing
07613327045239	MRH Tibial Bearing Component
07613327045222	MRH Tibial Bearing Component
07613327045215	MRH Tibial Rotating Component
07613327045208	MRH Tibial Rotating Component
07613327045192	MRH Knee Femoral Component
07613327045185	MRH Knee Femoral Component
07613327045178	MRH Knee Femoral Component
07613327045161	MRH Knee Femoral Component
07613327045154	MRH Knee Femoral Component
07613327045147	MRH Knee Femoral Component
07613327045130	MRH Knee Femoral Component
07613327045123	MRH Knee Femoral Component
07613327045109	MRH Knee Femoral Component
07613327043884	MRH Knee Tibial Insert
07613327043860	MRH Knee Tibial Insert
07613327043853	MRH Knee Tibial Insert
07613327043846	MRH Knee Tibial Insert
07613327043839	MRH Knee Tibial Insert
07613327043822	MRH Knee Tibial Insert
07613327043815	MRH Knee Tibial Insert
07613327043808	MRH Knee Tibial Insert
07613327043792	MRH Knee Tibial Insert
07613327043785	MRH Knee Tibial Insert
07613327043778	MRH Tibial Bearing Component
07613327033786	Tibial Bearing Component
07613327033762	Tibial Bearing Component
07613327033755	Tibial Bearing Component