Intermedullary Brush
FDA 510(k) K771016 · Howmedica Corp.
510(k) numberK771016
Submission
- Device name
- Intermedullary Brush
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- June 6, 1977
- Decision date
- January 12, 1978
- 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 |
| 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 |
| K771745 | Rasps for Scraping BoneHTR · Traditional | Depuy, Inc. | 09/28/1977SE |
| K760109 | Prosthesis, Total Hip-RaspHTR · Traditional | Orthopedic Equipment Co., Inc. | 07/20/1976SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Intermedullary Brush cleared by the FDA?
Intermedullary Brush (K771016) received a 510(k) decision of Substantially Equivalent on January 12, 1978, 220 days after the submission was received.
What is the product code of K771016?
The FDA product code is HTR – Rasp, a Class I (low risk) device regulated under 21 CFR 878.4800.