Rasp
FDA product code HTR · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
9510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870349 | Biodynamics Femoral Canal Brush #1201HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K870333 | Biodynamics Small Joint Brush #1203HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K870329 | Acetabular Brush #1202 & Femoral Con. Brush #1202HTR · Traditional | Biodynamic Technologies, Inc. | 02/13/1987SE |
| K813093 | Richards Acetabular BrushHTR · Traditional | Richard'S Medical Equip., Inc. | 11/20/1981SE |
| K812506 | The ArthrofileHTR · Traditional | Dyonics, Inc. | 09/24/1981SE |
| K780771 | Micro RaspsHTR · Traditional | Amsco Co. | 05/16/1978SE |
| K771016 | Intermedullary BrushHTR · Traditional | Howmedica Corp. | 01/12/1978SE |
| K771745 | Rasps for Scraping BoneHTR · Traditional | Depuy, Inc. | 09/28/1977SE |
| K760109 | Prosthesis, Total Hip-RaspHTR · Traditional | Orthopedic Equipment Co., Inc. | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1634-2013 Class II | Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | Surgical Instrument Service And Savings, Inc. | 05/03/2013Terminated |
| Z-0566-2009 | Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |