Partial Ossicular Replacement Prostheses
FDA 510(k) K060518 · Grace Medical, Inc.
510(k) numberK060518
Submission
- Device name
- Partial Ossicular Replacement Prostheses
- Applicant
- Grace Medical, Inc.
Memphis, TN, US - Received
- February 27, 2006
- Decision date
- June 28, 2006
- 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 |
| K112616 | Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisETB · Traditional | Heinz Kurz GmbH Medizintechnik | 02/08/2013SE |
| 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 |
| K033554 | Smart Offset Stapes Piston; Smart Isj ProsthesisETB · Traditional | Gyrus Ent LLC | 11/24/2003SE |
More from Gyrus Ent LLC
| 510(k) | Device | Decision |
|---|---|---|
| K260266 | Tympendi (810)KHJ · Traditional | 08/18/2026SE |
| K232059 | Tympanostomy TubesETD · Traditional | 11/24/2023SE |
| K161376 | DragonFly Surgical Drill SystemERL · Traditional | 08/25/2016SE |
| K091187 | Grace Dynamic TorpETA · Traditional | 09/14/2009SE |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesETB · Traditional | 04/17/2008SE |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…ETB · Traditional | 12/06/2006SE |
| K062672 | Grace Medical PC Coated Tympanostomy TubesETD · Traditional | 10/24/2006SE |
| K062385 | Blue PTFE (Fluoroplastic) Ventilation TubesETD · Traditional | 09/27/2006SE |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesETB · Traditional | 08/18/2006SE |
| K991394 | Stapes ProsthesesETB · Special | 05/18/1999SE |
Questions and answers
When was Partial Ossicular Replacement Prostheses cleared by the FDA?
Partial Ossicular Replacement Prostheses (K060518) received a 510(k) decision of Substantially Equivalent on June 28, 2006, 121 days after the submission was received.
What is the product code of K060518?
The FDA product code is ETB – Prosthesis, Partial Ossicular Replacement, a Class II (moderate risk) device regulated under 21 CFR 874.3450.