MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
FDA 510(k) clearance K020196 · decided 2002-02-15
Clearance details
- K-number
- K020196
- Device name
- MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
- Applicant
- Sulzer Spine-Tech
- Decision
- Substantially Equivalent
- Date received
- 2002-01-22
- Decision date
- 2002-02-15
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- MNH
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Reliance Spinal Screw System (K162066) | Reliance Medical Systems, LLC | 2016-12-02 |
| CastleLoc Spinal Fixation System (K162801) | L&K BIOMED Co., Ltd. | 2016-11-03 |
| FixxSure® X-Link (K162143) | Innovasis, Inc. | 2016-09-23 |
| Spinal fixation system (K161151) | Canwell Medical Co., Ltd. | 2016-09-21 |
| ANAX™ 5.5 Spinal System (K162189) | U&I Corporation | 2016-08-30 |
| HC Spinal System (K151362) | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| Zavation Spinal System (K153404) | Zavation, LLC | 2016-04-21 |
| Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (K160020) | Captiva Spine | 2016-03-02 |
| Spinal Inner Fixation System (K143013) | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| Romeo posterior osteosynthesis system (K151695) | Spineart | 2015-09-10 |
| CapLOX II/TowerLOX Pedicle Screw System (K151116) | Captiva Spine | 2015-06-26 |
| Republic Spine Dark Star Spinal System (K150283) | Republic Spine, LLC | 2015-04-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE (P980048/S003) | Sulzer Spine-Tech | 2004-10-06 |
| BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM (P980048/S002) | Sulzer Spine-Tech | 2002-06-19 |
| BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM (P980048/S001) | Sulzer Spine-Tech | 2001-05-02 |
| BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM (P980048) | Sulzer Spine-Tech | 2001-04-20 |