Space 360 Delivery System
FDA 510(k) K070351 · Dfine, Inc.
510(k) numberK070351
Submission
- Device name
- Space 360 Delivery System
- Applicant
- Dfine, Inc.
Cupertino, CA, US - Received
- February 6, 2007
- Decision date
- June 29, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
|---|---|---|
| K091310 | Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682GEI · Traditional | 08/11/2010SE |
| K090986 | Stabili Erx Bone Cement, Model 1135,STABILIT Vertebral Augmentation System (for Use W/…NDN · Traditional | 12/30/2009SE |
| K072496 | Modification to Space Cpsxl Bone CementNDN · Special | 10/05/2007SE |
| K061531 | Space Cpsxl Bone CementNDN · Traditional | 08/30/2006SE |
Questions and answers
When was Space 360 Delivery System cleared by the FDA?
Space 360 Delivery System (K070351) received a 510(k) decision of Substantially Equivalent on June 29, 2007, 143 days after the submission was received.
What is the product code of K070351?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.