FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K Number: K003384
·
Decision Nov 24, 2000
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
24
Review Days
24
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Basic Information
- Device Name
- VERSALINK TITANIUM ROD-TO-ROD COUPLERS
- K Number
- K003384
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteotech, Inc.
- Date Received
- October 31, 2000
- Decision Date
- November 24, 2000
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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| K051781 | GRAFTCAGE TLX | Dec 16, 2005 | Substantially Equivalent |
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| K053080 | GRAFTCAGE ACX | Dec 1, 2005 | Substantially Equivalent |