FDA 510(k) Application Details - K241314

Device Classification Name Plate, Bone

  More FDA Info for this Device
510(K) Number K241314
Device Name Plate, Bone
Applicant KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 US
Other 510(k) Applications for this Company
Contact Melissa Bachorski
Other 510(k) Applications for this Contact
Regulation Number 872.4760

  More FDA Info for this Regulation Number
Classification Product Code JEY
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/10/2024
Decision Date 08/16/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241314


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact