DYNESYS TOP-LOADING SPINAL SYSTEM
FDA 510(k) clearance K092234 · decided 2009-10-01
Clearance details
- K-number
- K092234
- Device name
- DYNESYS TOP-LOADING SPINAL SYSTEM
- Applicant
- Zimmer Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-23
- Decision date
- 2009-10-01
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- NQP
- 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 |
|---|---|---|
| CD HORIZON™ Spinal System (K203678) | Medtronic Sofamor Danek USA, Inc. | 2021-01-15 |
| CD Horizon™ Astute™ Spinal System (K191066) | Medtronic Sofamor Danek USA, Inc. | 2019-10-03 |
| CD Horizon™ Spinal System (K182928) | Medtronic Sofamor Danek USA, Inc. | 2019-01-11 |
| DYNESYS TOP-LOADING SPINAL SYSTEM (K133164) | Zimmer Spine, Inc. | 2014-01-16 |
| ZIMMER DTO PIN PRESS INSTRUMENT (K101704) | Zimmer Spine, Inc. | 2010-08-18 |
| DSS STABILIZATION SYSTEM (K101083) | Paradigm Spine, LLC | 2010-07-02 |
| MODIFICATION TO: DSS STABILIZATION SYSTEM (K091944) | Paradigm Spine, LLC | 2009-08-03 |
| TRANSITION STABILIZATION SYSTEM (K073439) | Globus Medical, Inc. | 2009-02-20 |
| DDS STABILIZATION SYSTEM (K080241) | Paradigm Spine, LLC | 2008-11-28 |
| DSS STABILIZATION SYSTEM (K080963) | Paradigm Spine | 2008-05-02 |
| ISOBAR SEMI-RIGID DUAL DAMPENER (K071261) | Scient'X | 2008-04-17 |
| BIOFLEX (K072321) | Biospine Co., Ltd. | 2008-03-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BAK VISTA INTERBODY FUSION CAGE (P950002/S014) | Zimmer Spine, Inc. | 2004-07-01 |
| VISTA LORDOTIC INTERBODY FUSION CAGE (P950002/S013) | Zimmer Spine, Inc. | 2004-01-29 |
| BAK VISTA INTERBODY FUSION CAGE (P950002/S012) | Zimmer Spine, Inc. | 2003-10-31 |
| BAK VISTA INTERBODY FUSION DEVICE (P950002/S011) | Zimmer Spine, Inc. | 2003-07-08 |
| BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE (P950002/S007) | Zimmer Spine, Inc. | 2002-05-01 |
| BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM (P950002/S009) | Zimmer Spine, Inc. | 2001-04-03 |
| BAK/L INTERBODY FUSION SYSTEM (P950002/S008) | Zimmer Spine, Inc. | 1999-12-20 |
| BAK INTERBODY FUSION SYSTEM (P950002/S006) | Zimmer Spine, Inc. | 1998-05-12 |