FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K Number: K964416
·
Decision Mar 17, 1997
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
402
Review Days
164
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Basic Information
- Device Name
- SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
- K Number
- K964416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Synthes (Usa)
- Date Received
- October 4, 1996
- Decision Date
- March 17, 1997
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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