Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ECLIPSE FLAT RIBBON PISTON | 473-500 | Grace Medical, Inc. | ETB | 00844505010481 |
| ECLIPSE PISTON | 467-550 | Grace Medical, Inc. | ETB | 00844505010184 |
| ECLIPSE MALLEUS PISTON | 440-650 | Grace Medical, Inc. | ETB | 00844505010214 |
| ECLIPSE PISTON | 468-425 | Grace Medical, Inc. | ETB | 00844505002004 |
| ECLIPSE PISTON | 468-500 | Grace Medical, Inc. | ETB | 00844505002035 |
| SUPER E PISTON | 466-400 | Grace Medical, Inc. | ETB | 00844505001861 |
| ECLIPSE PISTON | 468-400 | Grace Medical, Inc. | ETB | 00844505001991 |
| ECLIPSE MALLEUS PISTON | 440-550 | Grace Medical, Inc. | ETB | 00844505010191 |
| ECLIPSE FLAT RIBBON PISTON | 472-500 | Grace Medical, Inc. | ETB | 00844505009386 |
| ECLIPSE MALLEUS PISTON | 440-700 | Grace Medical, Inc. | ETB | 00844505010221 |
| ECLIPSE TITANIUM PISTON | 470-450 | Grace Medical, Inc. | ETB | 00844505006705 |
| ECLIPSE TITANIUM PISTON | 470-425 | Grace Medical, Inc. | ETB | 00844505006699 |
| ECLIPSE DE LA CRUZ PISTON | 469-475 | Grace Medical, Inc. | ETB | 00844505005968 |
| ECLIPSE PISTON | 471-475 | Grace Medical, Inc. | ETB | 00844505006767 |
| ECLIPSE PISTON | 468-375 | Grace Medical, Inc. | ETB | 00844505001984 |
| ECLIPSE TITANIUM PISTON | 470-400 | Grace Medical, Inc. | ETB | 00844505006682 |
| ECLIPSE PISTON | 467-375 | Grace Medical, Inc. | ETB | 00844505001915 |
| NITINIL SRP | 758-475 | Grace Medical, Inc. | ETB | 00844505009805 |
| ECLIPSE PISTON | 468-600 | Grace Medical, Inc. | ETB | 00844505002042 |
| NITINIL SRP | 758-425 | Grace Medical, Inc. | ETB | 00844505009782 |
| ECLIPSE MALLEUS PISTON | 442-800 | Grace Medical, Inc. | ETB | 00844505006521 |
| ECLIPSE MALLEUS PISTON MODIFIED LOOP | 443-800 | Grace Medical, Inc. | ETB | 00844505011136 |
| ECLIPSE FLAT RIBBON PISTON | 472-400 | Grace Medical, Inc. | ETB | 00844505009348 |
| ECLIPSE PISTON | 464-800 | Grace Medical, Inc. | ETB | 00844505013895 |
| ECLIPSE FLAT RIBBON PISTON | 473-425 | Grace Medical, Inc. | ETB | 00844505010450 |