FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K Number: K030862
·
Decision Apr 17, 2003
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
45
Review Days
30
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Basic Information
- Device Name
- BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
- K Number
- K030862
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blackstone Medical, Inc.
- Date Received
- March 18, 2003
- Decision Date
- April 17, 2003
- Product Code
- MNI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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| K082797 | BLACKSTONE PEDICLE SCREW SYSTEM | Oct 17, 2008 | Substantially Equivalent |
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