Grace Dynamic Torp
FDA 510(k) K091187 · Grace Medical, Inc.
510(k) numberK091187
Submission
- Device name
- Grace Dynamic Torp
- Applicant
- Grace Medical, Inc.
Memphis, TN, US - Received
- April 23, 2009
- Decision date
- September 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…ETA · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| 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 |
| K001902 | Bojrab Universal Long Imlant, Model TBDETA · Traditional | Gyrus Ent LLC | 07/10/2000SE |
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| K260266 | Tympendi (810)KHJ · Traditional | 08/18/2026SE |
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| K161376 | DragonFly Surgical Drill SystemERL · Traditional | 08/25/2016SE |
| 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 |
| K060518 | Partial Ossicular Replacement ProsthesesETB · Traditional | 06/28/2006SE |
| K991394 | Stapes ProsthesesETB · Special | 05/18/1999SE |
Questions and answers
When was Grace Dynamic Torp cleared by the FDA?
Grace Dynamic Torp (K091187) received a 510(k) decision of Substantially Equivalent on September 14, 2009, 144 days after the submission was received.
What is the product code of K091187?
The FDA product code is ETA – Replacement, Ossicular Prosthesis, Total, a Class II (moderate risk) device regulated under 21 CFR 874.3495.