The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Smith & Nephew Porps & Torps.
| Device ID | K002737 |
| 510k Number | K002737 |
| Device Name: | SMITH & NEPHEW PORPS & TORPS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Alicia Farage |
| Correspondent | Alicia Farage GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-01 |
| Decision Date | 2000-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925022775 | K002737 | 000 |
| 00821925023505 | K002737 | 000 |
| 00821925023512 | K002737 | 000 |
| 00821925023529 | K002737 | 000 |
| 00821925023550 | K002737 | 000 |
| 00821925024144 | K002737 | 000 |
| 00821925024373 | K002737 | 000 |
| 00821925024380 | K002737 | 000 |
| 00821925024397 | K002737 | 000 |
| 00821925023482 | K002737 | 000 |
| 00821925023444 | K002737 | 000 |
| 00821925022782 | K002737 | 000 |
| 00821925022805 | K002737 | 000 |
| 00821925022836 | K002737 | 000 |
| 00821925022843 | K002737 | 000 |
| 00821925022850 | K002737 | 000 |
| 00821925022867 | K002737 | 000 |
| 00821925023376 | K002737 | 000 |
| 00821925023406 | K002737 | 000 |
| 00821925024403 | K002737 | 000 |
| 00821925024410 | K002737 | 000 |
| 00821925024427 | K002737 | 000 |
| 00821925025547 | K002737 | 000 |
| 00821925025554 | K002737 | 000 |
| 00821925025660 | K002737 | 000 |
| 00821925025677 | K002737 | 000 |
| 00821925025684 | K002737 | 000 |
| 00821925025691 | K002737 | 000 |
| 00821925030534 | K002737 | 000 |
| 00821925030541 | K002737 | 000 |
| 00821925025530 | K002737 | 000 |
| 00821925025523 | K002737 | 000 |
| 00821925024434 | K002737 | 000 |
| 00821925024960 | K002737 | 000 |
| 00821925024977 | K002737 | 000 |
| 00821925024984 | K002737 | 000 |
| 00821925024991 | K002737 | 000 |
| 00821925025004 | K002737 | 000 |
| 00821925025509 | K002737 | 000 |
| 00821925025516 | K002737 | 000 |
| 00821925030558 | K002737 | 000 |