DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
FDA 510(k) clearance K980447 · decided 1998-04-14
Clearance details
- K-number
- K980447
- Device name
- DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1998-02-05
- Decision date
- 1998-04-14
- Days to decision
- 68 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
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| 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 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| DePuy Ceramax Ceramic Total Hip System (P070026/S114) | DePuy Orthopaedics, Inc. | 2025-03-19 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |