FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
K Number: K072183
·
Decision Sep 5, 2007
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
19
Review Days
30
Basic Information
- Device Name
- ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
- K Number
- K072183
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZIMMER SPINE, INC.
- Date Received
- August 6, 2007
- Decision Date
- September 5, 2007
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by ZIMMER SPINE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K150896 | Vitality Spinal Fixation System | Aug 31, 2015 | Substantially Equivalent |
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| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Oct 29, 2014 | Substantially Equivalent |
| K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM | Sep 23, 2014 | Substantially Equivalent |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | Jun 2, 2014 | Substantially Equivalent |
| K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | May 21, 2014 | Substantially Equivalent |
| K132894 | OPTIO-C ANTERIOR CERVICAL SYSTEM | Jan 16, 2014 | Substantially Equivalent |
| K133086 | TITLE 2 POLYAXIAL SPINAL SYSTEM | Nov 27, 2013 | Substantially Equivalent |
| K132884 | PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM | Nov 25, 2013 | Substantially Equivalent |
| K131980 | SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM | Sep 4, 2013 | Substantially Equivalent |