Femrod and Femrod Recon Insert
FDA 510(k) K935383 · Applied Osteo Systems, Inc.
510(k) numberK935383
Submission
- Device name
- Femrod and Femrod Recon Insert
- Applicant
- Applied Osteo Systems, Inc.
Walnut Creek, CA, US - Received
- November 8, 1993
- Decision date
- March 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K933995 | True/Flextm Femur Rods, Caps, Screws and InstrumentationHSB · Traditional | 01/27/1995SE |
| K944501 | True/Flex Intramedullary Rod End-CapHSB · Traditional | 11/28/1994SE |
| K941048 | True/Lok Monolateral/Bilateral FixatorLXT · Traditional | 10/03/1994SE |
| K943160 | Interference ScrewHWC · Traditional | 09/30/1994SN |
| K934148 | True/Flex Clavicle RodsHSB · Traditional | 02/22/1994SE |
| K932853 | Pin Holders, Transfixing Pins, Ol Wires, Half PinsJEL · Traditional | 02/22/1994SE |
| K931578 | Texas Scottish Rite Easy/Lock FixatorJEC · Traditional | 02/22/1994SE |
| K926465 | Femoral Intramedullary RodsJDS · Traditional | 08/25/1993SE |
| K924657 | True/Flex Metatarsal RodsKTW · Traditional | 11/24/1992SE |
| K924656 | True/ Flex Fibula RodsHSB · Traditional | 11/24/1992SE |
Questions and answers
When was Femrod and Femrod Recon Insert cleared by the FDA?
Femrod and Femrod Recon Insert (K935383) received a 510(k) decision of Substantially Equivalent on March 21, 1995, 498 days after the submission was received.
What is the product code of K935383?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.