Stapes Prostheses
510(k) K991394
Stapes Prostheses is a Class II device made by Grace Medical, Inc., cleared under FDA 510(k) K991394 on 18 May 1999, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991394 | Date18 May 1999 | StatusActive |
Official records
- FDA 510(k) database K991394
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ETB
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3450
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ETB (Prosthesis, Partial Ossicular Replacement).
- mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) by MED-EL Elektromedizinische Geräte GmbH
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- INCUS PROSTHESIS by Richards Medical Co., Inc.
- RICHARDS PORP by Smith & Nephew Richards, Inc.
- CAP PORP, CAP TORP by Gyrus Ent LLC
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- Exmoor Teflon Loop Replacement Prosthesis by Exmoor Plastics, Ltd.
- Drumto Stapes Prosthesis by Humboldt Products
- CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 by Heinz Kurz GmbH Medizintechnik