510(k) K063606
- Device
- MODIFICATION TO STAXX FX SYSTEM
- Applicant
- SPINE WAVE, INC.
- 510(k) number
- K063606
- Product code
- OBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-04-13
- Date received
- 2006-12-01
- Regulation
- 888.3027
- Classification name
- Cement, Bone, Pre-formed, Modular, Polymeric, Vertebroplasty
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD K SMITH
- Address
- Two Enterprise Dr. Suite 302 Shelton CT US 06484 06484
Source Documents#
Legacy Summary#
summary
FDA Review#
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