KYPHON ELEMENT Inflatable Bone Tamp
FDA 510(k) clearance K151532 · decided 2015-07-23
Clearance details
- K-number
- K151532
- Device name
- KYPHON ELEMENT Inflatable Bone Tamp
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-06-08
- Decision date
- 2015-07-23
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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