FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM
K Number: K980288
·
Decision Jul 29, 1998
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
4
Review Days
184
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Basic Information
- Device Name
- SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM
- K Number
- K980288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Spine-Tech, Inc.
- Date Received
- January 26, 1998
- Decision Date
- July 29, 1998
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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