Ultimax Trochanteric Intramedullary Rod System
FDA 510(k) K990436 · Biodynamic Technologies, Inc.
510(k) numberK990436
Submission
- Device name
- Ultimax Trochanteric Intramedullary Rod System
- Applicant
- Biodynamic Technologies, Inc.
Deerfield Beach, FL, US - Received
- February 11, 1999
- Decision date
- March 31, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K990513 | Ultimax Cortical Bone ScrewsHWC · Traditional | 03/17/1999SE |
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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 |
| K962846 | Ez-Fix Compression Hip/Supracondylar Screw (CHS) SystemLXT · Traditional | 10/23/1996SE |
Questions and answers
When was Ultimax Trochanteric Intramedullary Rod System cleared by the FDA?
Ultimax Trochanteric Intramedullary Rod System (K990436) received a 510(k) decision of Substantially Equivalent on March 31, 1999, 48 days after the submission was received.
What is the product code of K990436?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.