MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
FDA 510(k) clearance K992276 · decided 1999-10-01
Clearance details
- K-number
- K992276
- Device name
- MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
- Applicant
- Sulzer Spine-Tech
- Decision
- Substantially Equivalent
- Date received
- 1999-07-07
- Decision date
- 1999-10-01
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- MNI
- 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 |
|---|---|---|
| Mikron Spinal Fixation System (K171497) | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 |
| LumFix Spinal Fixation Sytem (K160731) | CG Bio Co., Ltd. | 2016-10-04 |
| Double Medical Universal Spine System (K151458) | Double Medical Technology, Inc. | 2016-08-22 |
| MySpine Pedicle Screw Placement Guides - LP (K153273) | Medacta International S.A. | 2016-06-29 |
| LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (K160124) | Spinevision S.A. | 2016-04-04 |
| Premier (K160320) | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 |
| Sniper (R) Spine System (K160003) | Spine Wave, Inc. | 2016-02-26 |
| YAHUA Spinal System (K152324) | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 |
| FIREFLY Pedicle Screw Navigation Guide (K143222) | Mighty Oak Medical, Inc. | 2015-12-11 |
| WASTON General Spinal System (K150684) | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 |
| X-spine Pedicle Screw System (K152132) | X-Spine Systems, Inc. | 2015-09-25 |
| Gemmed pedicle screw spinal system (K151592) | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 |
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 |