Modification to Scandius Tritis Tibial Acl Reconstruction System
FDA 510(k) K063499 · Scandius Biomedical, Inc.
510(k) numberK063499
Submission
- Device name
- Modification to Scandius Tritis Tibial Acl Reconstruction System
- Applicant
- Scandius Biomedical, Inc.
Littleton, MA, US - Received
- November 20, 2006
- Decision date
- December 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K063497 | Modification to Scandius Tritis Absorbable Tibial Reconstruction SystemMAI · Special | 12/19/2006SE |
| K060522 | Scandius Tritis Absorbable Tibial Reconstruction SystemMAI · Traditional | 04/11/2006SE |
| K052810 | Scandius Tritis Tibial Acl Reconstruction SystemMBI · Traditional | 12/20/2005SE |
| K041961 | Scandius Absorbable Acl Reconstruction SystemHWC · Traditional | 10/20/2004SE |
| K041749 | Scandius Acl Reconstruction SystemHWC · Traditional | 09/08/2004SE |
Questions and answers
When was Modification to Scandius Tritis Tibial Acl Reconstruction System cleared by the FDA?
Modification to Scandius Tritis Tibial Acl Reconstruction System (K063499) received a 510(k) decision of Substantially Equivalent on December 19, 2006, 29 days after the submission was received.
What is the product code of K063499?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.