FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K Number: K013558
·
Decision Jan 23, 2002
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
655
Applicant Total
45
Review Days
90
Basic Information
- Device Name
- BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
- K Number
- K013558
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BLACKSTONE MEDICAL, INC.
- Date Received
- October 25, 2001
- Decision Date
- January 23, 2002
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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