Total Knee Kit
FDA 510(k) K932918 · Biodynamic Technologies, Inc.
510(k) numberK932918
Submission
- Device name
- Total Knee Kit
- Applicant
- Biodynamic Technologies, Inc.
Arlington, VA, US - Received
- June 15, 1993
- Decision date
- September 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| 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 Total Knee Kit cleared by the FDA?
Total Knee Kit (K932918) received a 510(k) decision of Substantially Equivalent on September 1, 1994, 443 days after the submission was received.
What is the product code of K932918?
The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.