BIOPLATE RIGID FIXATION BONE PLATING SYSTEM

Plate, Bone

BIOMEDICS

The following data is part of a premarket notification filed by Biomedics with the FDA for Bioplate Rigid Fixation Bone Plating System.

Pre-market Notification Details

• Device ID: K953273
• 510k Number: K953273
• Device Name: BIOPLATE RIGID FIXATION BONE PLATING SYSTEM
• Classification: Plate, Bone
• Applicant: BIOMEDICS 536 RIMPAU BLVD. Los Angeles, CA 90020
• Contact: Carol E Jones
• Correspondent: Carol E Jones; BIOMEDICS 536 RIMPAU BLVD. Los Angeles, CA 90020
• Product Code: JEY
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-13
• Decision Date: 1995-09-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M384SCE806051	K953273	000
M384SCE407010	K953273	000
M384SCE407051	K953273	000
M384SCE40705US1	K953273	000
M384SCE409010	K953273	000
M384SCE409051	K953273	000
M384SCE40905US1	K953273	000
M384SCE411010	K953273	000
M384SCE411051	K953273	000
M384SCE40605US1	K953273	000
M384SCE406051	K953273	000
M384SCE21205US1	K953273	000
M384SCE404010	K953273	000
M384SCE404051	K953273	000
M384SCE40405US1	K953273	000
M384SCE405010	K953273	000
M384SCE405051	K953273	000
M384SCE40505US1	K953273	000
M384SCE406010	K953273	000
M384SCE41105US1	K953273	000
M384SCE413010	K953273	000
M384SCE80305US1	K953273	000
M384SCE804010	K953273	000
M384SCE804051	K953273	000
M384SCE80405US1	K953273	000
M384SCE805010	K953273	000
M384SCE805051	K953273	000
M384SCE80505US1	K953273	000
M384SCE806010	K953273	000
M384SCE803051	K953273	000
M384SCE803010	K953273	000
M384SCE413051	K953273	000
M384SCE41305US1	K953273	000
M384SCE415010	K953273	000
M384SCE415051	K953273	000
M384SCE41505US1	K953273	000
M384SCE417010	K953273	000
M384SCE417051	K953273	000
M384SCE41705US1	K953273	000
M384SCE212051	K953273	000
M384SCE212010	K953273	000
M384SCE21005US1	K953273	000
M384812017US1	K953273	000
M3848130170	K953273	000
M3848130431	K953273	000
M384813043US1	K953273	000
M3848130550	K953273	000
M384813055CP1	K953273	000
M384813055US0	K953273	000
M3848131641	K953273	000
M3848120171	K953273	000
M384812016US1	K953273	000
M3848120121	K953273	000
M384812012US1	K953273	000
M3848120131	K953273	000
M3848120141	K953273	000
M384812014US1	K953273	000
M3848120151	K953273	000
M384812015US1	K953273	000
M3848120161	K953273	000
M3848131650	K953273	000
M3848134931	K953273	000
M384SCE206010	K953273	000
M384SCE206051	K953273	000
M384SCE20605US1	K953273	000
M384SCE208010	K953273	000
M384SCE208051	K953273	000
M384SCE20805US1	K953273	000
M384SCE210010	K953273	000
M384SCE210051	K953273	000
M384SCE20505US1	K953273	000
M384SCE205051	K953273	000
M3848134941	K953273	000
M384SCE203010	K953273	000
M384SCE203051	K953273	000
M384SCE20305US1	K953273	000
M384SCE204010	K953273	000
M384SCE204051	K953273	000
M384SCE20405US1	K953273	000
M384SCE205010	K953273	000
M3848120111	K953273	000
M3848158820	K953273	000
M384SCR410051	K953273	000
M384SCR411010	K953273	000
M384SCR411051	K953273	000
M384SCR41105US1	K953273	000
M384SCR41201	K953273	000
M384SCR412051	K953273	000
M384SCR413010	K953273	000
M384SCR413051	K953273	000
M384SCR410010	K953273	000
M384SCR40905US1	K953273	000
M384SCR40605US1	K953273	000
M384SCR407010	K953273	000
M384SCR407051	K953273	000
M384SCR40705US1	K953273	000
M384SCR408010	K953273	000
M384SCR408051	K953273	000
M384SCR409010	K953273	000
M384SCR409051	K953273	000
M384SCR41305US1	K953273	000
M384SCR414010	K953273	000
M384SCR80405US1	K953273	000
M384SCR805051	K953273	000
M384SCR80505US1	K953273	000
M384SCR806051	K953273	000
M384SCR80605US1	K953273	000
M384SCR808051	K953273	000
M384SCR80805US1	K953273	000
M384SCR810051	K953273	000
M384SCR804051	K953273	000
M384SCR80305US1	K953273	000
M384SCR414051	K953273	000
M384SCR415010	K953273	000
M384SCR415051	K953273	000
M384SCR41505US1	K953273	000
M384SCR417010	K953273	000
M384SCR417051	K953273	000
M384SCR41705US1	K953273	000
M384SCR803051	K953273	000
M384SCR406051	K953273	000
M384SCR406010	K953273	000
M384SCR40505US1	K953273	000
M384SCR20401US0	K953273	000
M384SCR204051	K953273	000
M384SCR20405US1	K953273	000
M384SCR205010	K953273	000
M384SCR205051	K953273	000
M384SCR20505US1	K953273	000
M384SCR206010	K953273	000
M384SCR206051	K953273	000
M384SCR204010	K953273	000
M384SCR20305US1	K953273	000
M384SCE808010	K953273	000
M384SCE808051	K953273	000
M384SCE810010	K953273	000
M384SCE810051	K953273	000
M384SCE812010	K953273	000
M384SCE812051	K953273	000
M384SCR203010	K953273	000
M384SCR203051	K953273	000
M384SCR20605US1	K953273	000
M384SCR208010	K953273	000
M384SCR214010	K953273	000
M384SCR21401US0	K953273	000
M384SCR214051	K953273	000
M384SCR404010	K953273	000
M384SCR404051	K953273	000
M384SCR40405US1	K953273	000
M384SCR405010	K953273	000
M384SCR405051	K953273	000
M384SCR21205US1	K953273	000
M384SCR212051	K953273	000
M384SCR208051	K953273	000
M384SCR20805US1	K953273	000
M384SCR208501	K953273	000
M384SCR210010	K953273	000
M384SCR210051	K953273	000
M384SCR21005US1	K953273	000
M384SCR210501	K953273	000
M384SCR212010	K953273	000
M384SCE80605US1	K953273	000