Shea Torp, Otology Implant
FDA 510(k) K760433 · Richard'S Medical Equip., Inc.
510(k) numberK760433
Submission
- Device name
- Shea Torp, Otology Implant
- Applicant
- Richard'S Medical Equip., Inc.
Mchenry, IL, US - Received
- August 16, 1976
- Decision date
- October 5, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETA – Replacement, Ossicular Prosthesis, Total
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3495
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code ETA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691)…ETA · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…ETA · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K091187 | Grace Dynamic TorpETA · Traditional | Grace Medical, Inc. | 09/14/2009SE |
| K083780 | Superelelastic Nitinol Piston, Superelastic Nitinol Trimmable Piston, Model…ETA · Traditional | Audio Technologies S.R.L. | 03/23/2009SE |
| K043375 | Fisch Titanium Middle Ear ProsthesesETA · Traditional | Karl Storz Endoscopy | 01/24/2005SE |
| K042503 | Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMETA · Traditional | Heinz Kurz GmbH Medizintechnik | 10/01/2004SE |
| K030492 | Titanium Ossicular Replacment SystemETA · Traditional | Invotec International, Inc. | 03/03/2003SE |
| K002378 | Modular Porp and Torp Model TBDETA · Traditional | Gyrus Ent LLC | 08/29/2000SE |
| K001406 | Ha/Gold Total and Partial, Regular and Offset, Ossicular Replacement ProsthesesETA · Traditional | Mednet Locator, Inc. | 08/08/2000SE |
| K001404 | Gold Total and Partial, Regular and Offset, Ossicular Replacement Prostheses, Gold Total…ETA · Traditional | Mednet Locator, Inc. | 08/08/2000SE |
More from Mednet Locator, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830793 | Patient Guided Elbow & Shoulder ExercBXB · Traditional | 06/16/1983SE |
| K823837 | RMC Total Knee SystemMBV · Traditional | 03/29/1983SE |
| K823726 | Spectron Conversion Endoprosthesis CupKWY · Traditional | 03/09/1983SE |
| K823724 | Spectron Neck Replacement ProsthesisJDI · Traditional | 03/09/1983SE |
| K823723 | Spectron Proximal Femoral ProsthesisJDI · Traditional | 03/09/1983SE |
| K823727 | Spectron Primary Stem Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K823722 | Spectron Long, Straight Femoral ProsthesJDI · Traditional | 03/08/1983SE |
| K830153 | Richards Intra-Articular Shaver BladesGEY · Traditional | 02/28/1983SE |
| K830154 | Colles Fracture FrameJEC · Traditional | 02/02/1983SE |
| K823729 | Spectron Metal Back Acetabular ComponentJDI · Traditional | 01/21/1983SE |
Questions and answers
When was Shea Torp, Otology Implant cleared by the FDA?
Shea Torp, Otology Implant (K760433) received a 510(k) decision of Substantially Equivalent on October 5, 1976, 50 days after the submission was received.
What is the product code of K760433?
The FDA product code is ETA – Replacement, Ossicular Prosthesis, Total, a Class II (moderate risk) device regulated under 21 CFR 874.3495.