FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNI-T UNI-THREAD SPINAL SYSTEM
K Number: K021510
·
Decision Aug 1, 2002
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
12
Review Days
84
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Basic Information
- Device Name
- UNI-T UNI-THREAD SPINAL SYSTEM
- K Number
- K021510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine Vision, Inc.
- Date Received
- May 9, 2002
- Decision Date
- August 1, 2002
- 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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Other Clearances by Spine Vision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052406 | UNI-THREAD SPINAL SYSTEM | Nov 7, 2005 | Substantially Equivalent |
| K030526 | PEDIGUARD NERVE DETECTOR SYSTEM | Dec 29, 2004 | Substantially Equivalent |
| K042930 | SPACEVISION CAGE SYSTEM | Dec 28, 2004 | Substantially Equivalent |
| K042640 | UNI-THREAD SPINAL SYSTEM | Nov 23, 2004 | Substantially Equivalent |
| K033508 | PLUS PIVOT LINK UNIVERSAL SYSTEM | Jan 27, 2004 | Substantially Equivalent |
| K032398 | PLUS PIVOT LINK UNIVERSAL SYSTEM | Oct 31, 2003 | Substantially Equivalent |
| K022271 | PLUS PIVOT LINK UNIVERSAL SYSTEM | Sep 23, 2002 | Substantially Equivalent |
| K021507 | PLUS PIVOT LINK UNIVERSAL SYSTEM | Aug 1, 2002 | Substantially Equivalent |
| K013301 | UNI-T SPINAL SYSTEM | Feb 13, 2002 | Substantially Equivalent |
| K013312 | P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) | Feb 13, 2002 | Substantially Equivalent |