MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
FDA 510(k) clearance K953915 · decided 1996-02-15
Clearance details
- K-number
- K953915
- Device name
- MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-08-21
- Decision date
- 1996-02-15
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- MNH
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Depuy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |