FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K Number: K992276
·
Decision Oct 1, 1999
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
7
Review Days
86
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Basic Information
- Device Name
- MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
- K Number
- K992276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sulzer Spine-Tech
- Date Received
- July 7, 1999
- Decision Date
- October 1, 1999
- 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 Sulzer Spine-Tech
| K Number | Device Name | ||
|---|---|---|---|
| K022374 | CADENCE SPINAL FIXATION SYSTEM | Sep 24, 2002 | Substantially Equivalent |
| K020344 | RPX TITANIUM CEMNT RESTRICTOR | May 2, 2002 | Substantially Equivalent |
| K020196 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM | Feb 15, 2002 | Substantially Equivalent |
| K012173 | DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM | Sep 28, 2001 | Substantially Equivalent |
| K012305 | MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM | Aug 22, 2001 | Substantially Equivalent |
| K993067 | SILHOUETTE SPINAL FIXATION SYSTEM | Nov 16, 1999 | Substantially Equivalent |