The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Ips Preprosthetic.
Device ID | K210228 |
510k Number | K210228 |
Device Name: | KLS Martin IPS Preprosthetic |
Classification | Implant, Subperiosteal |
Applicant | KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
Contact | Jennifer Damato |
Correspondent | Susan Leander KLS Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
Product Code | ELE |
CFR Regulation Number | 872.3645 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-28 |
Decision Date | 2022-07-08 |