Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis
FDA 510(k) K112616 · Heinz Kurz GmbH Medizintechnik
510(k) numberK112616
Submission
- Device name
- Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis
- Applicant
- Heinz Kurz GmbH Medizintechnik
Amsterdam, NL - Received
- September 8, 2011
- Decision date
- February 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ETB – Prosthesis, Partial Ossicular Replacement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3450
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code ETB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…ETB · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm)…ETB · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and…ETB · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…ETB · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisETB · Traditional | Heinz Kurz GmbH Medizintechnik | 12/02/2013SE |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 04/17/2008SE |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…ETB · Traditional | Grace Medical, Inc. | 12/06/2006SE |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 08/18/2006SE |
| K060518 | Partial Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 06/28/2006SE |
| K033554 | Smart Offset Stapes Piston; Smart Isj ProsthesisETB · Traditional | Gyrus Ent LLC | 11/24/2003SE |
More from Gyrus Ent LLC
| 510(k) | Device | Decision |
|---|---|---|
| K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisETB · Traditional | 12/02/2013SE |
| K071150 | Trocar Ventilation Tube/With Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015…ETD · Traditional | 12/12/2007SE |
| K042503 | Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMETA · Traditional | 10/01/2004SE |
| K033796 | Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BSKHJ · Traditional | 01/30/2004SE |
| K021479 | Clip Piston Awengen, Model# 1006 805 - 1006 861ETB · Special | 05/21/2002SE |
| K013573 | Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257ETB · Special | 11/09/2001SE |
| K011115 | Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007…MML · Special | 05/02/2001SE |
| K002221 | Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170ETB · Traditional | 08/09/2000SE |
| K001123 | Kurz Upper Eyelid Implant Sizers, Model 8000 111MML · Traditional | 04/21/2000SE |
| K000127 | Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10MML · Traditional | 04/12/2000SE |
Questions and answers
When was Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis cleared by the FDA?
Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis (K112616) received a 510(k) decision of Substantially Equivalent on February 8, 2013, 519 days after the submission was received.
What is the product code of K112616?
The FDA product code is ETB – Prosthesis, Partial Ossicular Replacement, a Class II (moderate risk) device regulated under 21 CFR 874.3450.