Acetabular Brush #1202 & Femoral Con. Brush #1202
FDA 510(k) K870329 · Biodynamic Technologies, Inc.
510(k) numberK870329
Submission
- Device name
- Acetabular Brush #1202 & Femoral Con. Brush #1202
- Applicant
- Biodynamic Technologies, Inc.
Arlington, VA, US - Received
- January 28, 1987
- Decision date
- February 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTR – Rasp
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTR
| 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 |
| 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 |
More from Orthopedic Equipment Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990436 | Ultimax Trochanteric Intramedullary Rod SystemHSB · Traditional | 03/31/1999SE |
| K990513 | Ultimax Cortical Bone ScrewsHWC · Traditional | 03/17/1999SE |
| K990481 | Ultimax Distal Radial (Volar) Locking Plate SystemHRS · Traditional | 03/17/1999SE |
| K981230 | Ultimax Distal Femoral Intramedullary Rod SystemHSB · Traditional | 06/01/1998SE |
| K980102 | Bti Humeral Intramedullary Rod SystemHSB · Traditional | 04/03/1998SE |
| K974756 | Bti Large (7.0MM) Cannulated Transfixing ScrewsHWC · Traditional | 03/12/1998SN |
| K972403 | Bti Cortical Bone ScrewsHWC · Traditional | 08/29/1997SE |
| K970897 | Bti Distal Femoral Intramedullary Rod SystemHSB · Traditional | 04/21/1997SE |
| K962706 | Ez-Fix Cannulated Screw SystemHWC · Traditional | 11/13/1996SE |
| K962987 | Ez-Fix Small Cannulated Screw SystemHWC · Traditional | 11/04/1996SE |
Questions and answers
When was Acetabular Brush #1202 & Femoral Con. Brush #1202 cleared by the FDA?
Acetabular Brush #1202 & Femoral Con. Brush #1202 (K870329) received a 510(k) decision of Substantially Equivalent on February 13, 1987, 16 days after the submission was received.
What is the product code of K870329?
The FDA product code is HTR – Rasp, a Class I (low risk) device regulated under 21 CFR 878.4800.