Forceps-Orthopedic
FDA 510(k) K890165 · Dhason Brothers, Inc.
510(k) numberK890165
Submission
- Device name
- Forceps-Orthopedic
- Applicant
- Dhason Brothers, Inc.
Hyattsville, MD, US - Received
- January 9, 1989
- Decision date
- February 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LXN – Probe, Test, Heart-Valve
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
Other 510(k)s with product code LXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881449 | Edwards-Duromedics Leaflet Probe, Model 1116LXN · Traditional | Baxter Healthcare Corp | 06/15/1988SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K890168 | Retractor, Self-RetainingLXH · Traditional | 02/13/1989SE |
| K890166 | Ronguer-OrthopedicLXH · Traditional | 02/13/1989SE |
| K890164 | Hudson Brace W/BurrsLXH · Traditional | 02/13/1989SE |
| K890163 | Austin Moore Hallow ChiselLXH · Traditional | 02/13/1989SE |
| K890162 | Extractor for Austin Moore Femoral HeadLXH · Traditional | 02/13/1989SE |
| K890161 | Thompson Type Rasp W/Tommy BarLXH · Traditional | 02/13/1989SE |
| K890160 | Gouges for Femoral HeadsLXH · Traditional | 02/13/1989SE |
| K890158 | RetractorsLXH · Traditional | 02/13/1989SE |
| K890157 | ForcepsLXH · Traditional | 02/13/1989SE |
| K890156 | Impactor for Femoral HeadLXH · Traditional | 02/13/1989SE |
Questions and answers
When was Forceps-Orthopedic cleared by the FDA?
Forceps-Orthopedic (K890165) received a 510(k) decision of Substantially Equivalent on February 13, 1989, 35 days after the submission was received.
What is the product code of K890165?
The FDA product code is LXN – Probe, Test, Heart-Valve, a Class I (low risk) device regulated under 21 CFR 870.4500.