INCOMPASS SPINAL FIXATION SYSTEM
FDA 510(k) clearance K021564 · decided 2002-10-25
Clearance details
- K-number
- K021564
- Device name
- INCOMPASS SPINAL FIXATION SYSTEM
- Applicant
- Spinal Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-13
- Decision date
- 2002-10-25
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13 recall (Z-1592-2008) | Abbott Spine | 2008-09-01 |