Modification of Depuy Ace Timax Medial Pilon Plate
FDA 510(k) K990120 · Depuy Ace Medical Co.
510(k) numberK990120
Submission
- Device name
- Modification of Depuy Ace Timax Medial Pilon Plate
- Applicant
- Depuy Ace Medical Co.
El Segundo, CA, US - Received
- January 13, 1999
- Decision date
- February 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K990392 | Depuy Ace Spider PlateHRS · Traditional | 03/23/1999SE |
| K984458 | Depuy Ace Spider PlateHRS · Traditional | 12/31/1998SE |
| K983853 | Depuy Ace Timax Meta PlateHRS · Traditional | 12/22/1998SE |
| K983265 | Depuy Ace Composite Locking NutHTN · Traditional | 10/26/1998SE |
| K982347 | Depuy Ace Timax Pilon PlateHRS · Traditional | 08/31/1998SE |
| K981775 | Depuy Ace Timax Calcaneal Peri-Articular PlateHRS · Traditional | 07/29/1998SE |
| K974245 | Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip…LXT · Traditional | 05/22/1998SE |
| K970503 | Depuy Ace Trochanteric Side PlateHRS · Traditional | 04/30/1997SE |
| K970202 | Depuy Ace Aim Titanium Tibial NailHSB · Traditional | 03/21/1997SE |
Questions and answers
When was Modification of Depuy Ace Timax Medial Pilon Plate cleared by the FDA?
Modification of Depuy Ace Timax Medial Pilon Plate (K990120) received a 510(k) decision of Substantially Equivalent on February 1, 1999, 19 days after the submission was received.
What is the product code of K990120?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.