Russell-Taylor Intramedullary Knee Fusion Nails
FDA 510(k) K893377 · Richards Medical Co., Inc.
510(k) numberK893377
Submission
- Device name
- Russell-Taylor Intramedullary Knee Fusion Nails
- Applicant
- Richards Medical Co., Inc.
Memphis, TN, US - Received
- May 1, 1989
- Decision date
- November 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
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| K896106 | Rogozinski Spinal System, Add'L ComponentsKWP · Traditional | 06/25/1990SN |
| K900628 | Modular Hip SystemLZO · Traditional | 05/09/1990SN |
| K896580 | Uni-Polar HeadLZY · Traditional | 02/15/1990SE |
| K895241 | Intramedullary Hip ScrewKTT · Traditional | 01/04/1990SE |
| K884824 | Tricon-M Total Knee SystemMBV · Traditional | 11/21/1989SN |
| K896204 | Zirconia Ceramic Head Add'L SizesLZO · Traditional | 11/20/1989SN |
| K895242 | Pappas Tri-Flange Ventilation TubeETD · Traditional | 11/17/1989SE |
| K885069 | Zirconia Ceramic Head (Yitria Stabilized)LZO · Traditional | 09/01/1989SN |
| K892366 | Porous Genesis Stemmed Tibial ComponentJWH · Traditional | 07/19/1989SN |
| K890132 | Porous Genesis Patellar and Stemless Tibial Comp.JWH · Traditional | 07/19/1989SN |
Questions and answers
When was Russell-Taylor Intramedullary Knee Fusion Nails cleared by the FDA?
Russell-Taylor Intramedullary Knee Fusion Nails (K893377) received a 510(k) decision of Substantially Equivalent on November 16, 1989, 199 days after the submission was received.
What is the product code of K893377?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.