SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k) clearance K013979 · decided 2002-02-13
Clearance details
- K-number
- K013979
- Device name
- SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- Spinal Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-03
- Decision date
- 2002-02-13
- Days to decision
- 72 days
- Clearance type
- Special
- 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 |
|---|---|---|
| SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybri recall (Z-0292-06) | Abbott Spine | 2005-12-17 |
| SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Conce recall (Z-0880-05) | Spinal Concepts, Inc | 2005-06-11 |