MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
FDA 510(k) clearance K991460 · decided 1999-05-19
Clearance details
- K-number
- K991460
- Device name
- MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
- Applicant
- Sofamor Danek
- Decision
- Substantially Equivalent
- Date received
- 1999-04-27
- Decision date
- 1999-05-19
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- MNH
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, 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 |
|---|---|---|
| INTER FIX TM THREADED FUSION DEVICE (P970015/S031) | Sofamor Danek | 2005-07-27 |
| LT-CAGE LUMBAR TAPERED FUSION DEVICE (P970015/S029) | Sofamor Danek | 2005-07-22 |
| LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK) (P970015/S030) | Sofamor Danek | 2005-02-04 |
| INTER FIX THREADED FUSION DEVICE (P970015/S028) | Sofamor Danek | 2004-07-19 |
| LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE (P970015/S026) | Sofamor Danek | 2004-04-16 |
| LT-CAGE LUMBAR TAPERED FUSION DEVICE (P970015/S027) | Sofamor Danek | 2004-04-16 |
| INTER FIX THREADED FUSION DEVICE (P970015/S025) | Sofamor Danek | 2003-09-17 |
| LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE (P970015/S022) | Sofamor Danek | 2003-09-10 |