Marcove Intramedullary Rod
FDA 510(k) K810957 · Hexcel Medical
510(k) numberK810957
Submission
- Device name
- Marcove Intramedullary Rod
- Applicant
- Hexcel Medical
Mchenry, IL, US - Received
- April 7, 1981
- Decision date
- April 17, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K840416 | HexceliteITG · Traditional | 03/23/1984SE |
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| K812687 | Brigham II Total Hip SystemJDG · Traditional | 10/02/1981SE |
| K812669 | Seattle II Total Hip SystemJDG · Traditional | 10/02/1981SE |
| K812068 | Proposed Controls for Dosimetric ReleaseLIB · Traditional | 09/08/1981SE |
| K811164 | Urethane Orthopaedic Casting TapeITG · Traditional | 05/27/1981SE |
| K810956 | Marcove Humeral RodHSB · Traditional | 04/17/1981SE |
| K810230 | Condylar Knee W/Metal Encapsulated TibHRY · Traditional | 03/06/1981SE |
| K800051 | Hexcel Femoral Component Hip ProsthesisJDG · Traditional | 01/28/1980SE |
| K800050 | Anitomic Total Hip SystemJDG · Traditional | 01/24/1980SE |
Questions and answers
When was Marcove Intramedullary Rod cleared by the FDA?
Marcove Intramedullary Rod (K810957) received a 510(k) decision of Substantially Equivalent on April 17, 1981, 10 days after the submission was received.
What is the product code of K810957?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.