ETA — Replacement, Ossicular Prosthesis, Total Class II
FDA product code ETA covers "Replacement, Ossicular Prosthesis, Total", a Class II medical device regulated under 21 CFR 874.3495. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ETA
- Device Class
- Class II
- Regulation Number
- 874.3495
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260719 | med-el elektromedizinische geräte | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (5869 | April 3, 2026 |
| K241269 | med-el elektromedizinische geräte | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO To | January 17, 2025 |
| K091187 | grace medical | GRACE DYNAMIC TORP | September 14, 2009 |
| K083780 | audio technologies | SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL0 | March 23, 2009 |
| K043375 | karl storz endoscopy | FISCH TITANIUM MIDDLE EAR PROSTHESES | January 24, 2005 |
| K042503 | heinz kurz gmbh medizintechnik | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | October 1, 2004 |
| K030492 | invotec international | TITANIUM OSSICULAR REPLACMENT SYSTEM | March 3, 2003 |
| K002378 | gyrus ent | MODULAR PORP AND TORP MODEL TBD | August 29, 2000 |
| K001406 | mednet locator | HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES | August 8, 2000 |
| K001404 | mednet locator | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GO | August 8, 2000 |
| K001902 | gyrus ent | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD | July 10, 2000 |
| K993583 | stryker | ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM | November 10, 1999 |
| K992138 | micromedics | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES | August 9, 1999 |
| K990601 | gyrus ent | BOJRAB MICRO-TORP, MODEL 7014-5845 | March 31, 1999 |
| K981088 | exmoor plastics | MILLS COLUMELLA PROSTHESIS | June 5, 1998 |
| K972735 | mednet locator | TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) | September 5, 1997 |
| K963899 | exmoor plastics | CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) | August 22, 1997 |
| K972585 | heinz kurz gmbh medizintechnik | AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESI | August 4, 1997 |
| K955615 | misten medical | MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS | December 22, 1995 |
| K954518 | trebay medical | TREBAY TOTAL RECTANGULAR HEAD | October 27, 1995 |