OPUS SPINAL SYSTEM
FDA 510(k) clearance K993402 · decided 1999-12-20
Clearance details
- K-number
- K993402
- Device name
- OPUS SPINAL SYSTEM
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-08
- Decision date
- 1999-12-20
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- MNI
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
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| 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 |
|---|---|---|
| Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027) | Howmedica Osteonics Corp. | 2025-09-17 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S026) | Howmedica Osteonics Corp. | 2025-05-23 |
| Trident® Acetabular System (P000013/S025) | Howmedica Osteonics Corp. | 2024-03-08 |
| Trident(R), ABC(R) (P000013/S024) | Howmedica Osteonics Corp. | 2024-01-23 |
| Trident Ceramic System (P000013/S021) | Howmedica Osteonics Corp. | 2023-12-20 |
| Trident(R), ABC(R) (P000013/S023) | Howmedica Osteonics Corp. | 2023-12-19 |
| Trident®, ABC® (P000013/S022) | Howmedica Osteonics Corp. | 2023-09-27 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S020) | Howmedica Osteonics Corp. | 2022-04-01 |