ETB — Prosthesis, Partial Ossicular Replacement Class II
FDA product code ETB covers "Prosthesis, Partial Ossicular Replacement", a Class II medical device regulated under 21 CFR 874.3450. 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
- ETB
- Device Class
- Class II
- Regulation Number
- 874.3450
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260718 | med-el elektromedizinische geräte | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (5 | April 3, 2026 |
| K260720 | med-el elektromedizinische geräte | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x | April 3, 2026 |
| K241261 | med-el elektromedizinische geräte | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis | January 17, 2025 |
| K241142 | med-el elektromedizinische geräte | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFI | January 17, 2025 |
| K130512 | heinz kurz gmbh medizintechnik | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES P | December 2, 2013 |
| K112616 | heinz kurz gmbh medizintechnik | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS | February 8, 2013 |
| K080070 | grace medical | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES | April 17, 2008 |
| K063374 | grace medical | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, | December 6, 2006 |
| K061853 | grace medical | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT | August 18, 2006 |
| K060518 | grace medical | PARTIAL OSSICULAR REPLACEMENT PROSTHESES | June 28, 2006 |
| K033554 | gyrus ent | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS | November 24, 2003 |
| K021479 | heinz kurz gmbh medizintechnik | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | May 21, 2002 |
| K013573 | heinz kurz gmbh medizintechnik | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 | November 9, 2001 |
| K010442 | heinz kurz | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 10 | March 8, 2001 |
| K003214 | gyrus ent | SMITH & NEPHEW PISTONS | October 31, 2000 |
| K002737 | gyrus ent | SMITH & NEPHEW PORPS & TORPS | October 12, 2000 |
| K002897 | xomed | TITANIUM MIDDLE EAR PROSTHESES | October 11, 2000 |
| K002464 | gyrus ent | SMITH & NEPHEW OFF-CENTERED PORP | August 29, 2000 |
| K002221 | heinz kurz gmbh medizintechnik | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 | August 9, 2000 |
| K001142 | audio technologies | AUDIO TECHNOLOGIES S:R.1 | June 23, 2000 |