FDA 510(k) Applications Submitted by APRIL LEE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120043 |
01/05/2012 |
CSM INTERNAL-R IMPLANT SYSTEM |
CSM IMPLANT |
| K130191 |
01/25/2013 |
MINT |
HANSBIOMED CORPORATION |
| K120503 |
02/21/2012 |
CMI IMPLANT IS II ACTIVE |
NEOBIOTECH CO., LTD. |
| K120538 |
02/22/2012 |
PALLS M SPINAL SYSTEM |
KOREA BONE BANK CO., LTD |
| K110577 |
03/01/2011 |
OSSEOFUSE DENTAL IMPLANT SYSTEM |
DYNAMIC INNOVATIONS INC. |
| K110955 |
04/05/2011 |
ANYRIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
| K111120 |
04/21/2011 |
CSM SUBMERGED-R IMPLANT SYSTEM |
CSMIMPLANT |
| K131289 |
05/06/2013 |
I-GEN |
MEGAGEN IMPLANT CO., LTD |
| K111362 |
05/16/2011 |
REXIOUS SPINAL FIXATION SYSTEM |
DIO MEDICAL CO., LTD. |
| K111364 |
05/16/2011 |
HAPTITE COATING IMPLANT SYSTEM |
DENTIS CO., LTD. |
| K131748 |
06/14/2013 |
OSSEOFUSE DENTAL IMPLANT SYSTEM |
OSSEOFUSE, INC. |
| K121862 |
06/26/2012 |
REX ANTERIOR CERVICAL PLATE SYSTEM |
DIO MEDICAL CO., LTD. |
| K111995 |
07/13/2011 |
XINGTM SPINE SYSTEM |
IMPLANOVA CO. LTD |
| K122231 |
07/26/2012 |
XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD |
| K122240 |
07/27/2012 |
BONE PLUS BCP EAGLE EYE |
MEGAGEN IMPLANT CO., LTD |
| K112196 |
08/01/2011 |
OCTOTMPORT |
DALIM SURGNET CORPORATION |
| K112540 |
09/01/2011 |
S-MINI IMPLANT SYSTEM |
NEOBIOTECH CO., LTD. |
| K112580 |
09/06/2011 |
COLLAGEN WOUND DRESSING |
DALIM TISSEN CO., LTD. |
| K122872 |
09/19/2012 |
INTERVERTEBRAL BODY FUSION DEVICE |
DIO MEDICAL CO., LTD. |
| K113324 |
11/10/2011 |
REXIOUS HOOK FIXATION SYSTEMS |
DIO MEDICAL CO., LTD. |
| K113554 |
12/01/2011 |
CMI IMPLANT IS SYSTEM |
NEOBIOTECH CO., LTD. |
| K123870 |
12/17/2012 |
XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD. |
| K123988 |
12/26/2012 |
ANYONETM INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD |
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