The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis.
| Device ID | K112616 |
| 510k Number | K112616 |
| Device Name: | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-1 Amsterdam, NL 1017 Ap |
| Contact | Kristina Bitzer |
| Correspondent | Kristina Bitzer HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-1 Amsterdam, NL 1017 Ap |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-08 |
| Decision Date | 2013-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EHKM10071611 | K112616 | 000 |
| EHKM10071041 | K112616 | 000 |
| EHKM10071051 | K112616 | 000 |
| EHKM10071061 | K112616 | 000 |
| EHKM10071071 | K112616 | 000 |
| EHKM10071081 | K112616 | 000 |
| EHKM10071091 | K112616 | 000 |
| EHKM10071111 | K112616 | 000 |
| EHKM10071531 | K112616 | 000 |
| EHKM10071541 | K112616 | 000 |
| EHKM10071551 | K112616 | 000 |
| EHKM10071561 | K112616 | 000 |
| EHKM10071571 | K112616 | 000 |
| EHKM10071581 | K112616 | 000 |
| EHKM10071591 | K112616 | 000 |
| EHKM10071031 | K112616 | 000 |