FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TRANS1 FACET SCREW
K Number: K073515
·
Decision Mar 11, 2008
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
9
Review Days
88
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Basic Information
- Device Name
- TRANS1 FACET SCREW
- K Number
- K073515
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trans1 Incorporated
- Date Received
- December 14, 2007
- Decision Date
- March 11, 2008
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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Other Clearances by Trans1 Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K120991 | TRANS1 INTERBODY FUSION SYSTEM | Aug 23, 2012 | Substantially Equivalent |
| K102334 | TRANS1 AXIALIF PLUS | Mar 14, 2011 | Substantially Equivalent |
| K100210 | TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T | Aug 26, 2010 | Substantially Equivalent |
| K092124 | AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II | Jan 21, 2010 | Substantially Equivalent |
| K073643 | TRANS1 AXIALIF 2-LEVEL OR II SYSTEM | Apr 28, 2008 | Substantially Equivalent |
| K073514 | TRANS1 AXIAL FIXATON SYSTEM | Jan 11, 2008 | Substantially Equivalent |
| K051856 | TRANS1 FACET SCREWS | Sep 26, 2005 | Substantially Equivalent |
| K050965 | TRANS1 AXIALIF SYSTEM | Jun 14, 2005 | Substantially Equivalent |