Cortoss Bone Augmentation Material
FDA 510(k) K080108 · Orthovita, Inc.
510(k) numberK080108
Submission
- Device name
- Cortoss Bone Augmentation Material
- Applicant
- Orthovita, Inc.
Malver, PA, US - Received
- January 15, 2008
- Decision date
- June 5, 2009
- 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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| K101171 | Orthovita PEEK SpacerODP · Traditional | 01/25/2011SE |
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Questions and answers
When was Cortoss Bone Augmentation Material cleared by the FDA?
Cortoss Bone Augmentation Material (K080108) received a 510(k) decision of Substantially Equivalent on June 5, 2009, 507 days after the submission was received.
What is the product code of K080108?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.