KYPHON HV-R Bone Cement
FDA 510(k) K180700 · Medtronic Sofamor Danek USA, Inc.
510(k) numberK180700
Submission
- Device name
- KYPHON HV-R Bone Cement
- Applicant
- Medtronic Sofamor Danek USA, Inc.
Memphis, TN, US - Received
- March 16, 2018
- Decision date
- May 18, 2018
- 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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| K253129 | Infinity OCT SystemNKG · Special | 10/24/2025SE |
| K251444 | Endoskeleton Interbody SystemsMAX · Traditional | 09/04/2025SE |
| K251395 | The Rialto SI Fusion SystemOUR · Traditional | 06/26/2025SE |
Questions and answers
When was KYPHON HV-R Bone Cement cleared by the FDA?
KYPHON HV-R Bone Cement (K180700) received a 510(k) decision of Substantially Equivalent on May 18, 2018, 63 days after the submission was received.
What is the product code of K180700?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.