CHARITE ARTIFICIAL DISC
FDA premarket approval P040006 · decided 2004-10-26
Approval details
- PMA number
- P040006
- Trade name
- CHARITE ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Depuy Spine, Inc.
- Date received
- 2004-02-13
- Decision date
- 2004-10-26
- Days to decision
- 256 days
- Decision code
- APWD
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Raynham, MA
- Statement
- APPROVAL FOR THE CHARITE ARTIFICIAL DISC. THE DEVICE IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS SHOULD HAVE NO MORE THAN 3 MM OF SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE CHARITE ARTIFICIAL DISC SHOULD HAVE FAILED AT LEAST SIX MONTHS OF CONSERVATIVE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CONFIDENCE Spinal Cement System (K201831) | Depuy Spine, Inc. | 2020-08-31 |
| EXPEDIUM VERSE SPINE SYSTEM (K142185) | Depuy Spine, Inc. | 2014-11-19 |
| EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (K111136) | Depuy Spine, Inc. | 2012-06-14 |
| VIPER SYSTEM (K121020) | Depuy Spine, Inc. | 2012-05-03 |
| MOUNTAINEER OCT SPINAL SYSTEM (K110353) | Depuy Spine, Inc. | 2011-04-07 |
| EXPEDIUM SYSTEM, VIPER SYSTEM (K110216) | Depuy Spine, Inc. | 2011-04-01 |
| VEPER SYSTEM, EXPEDIUM SYSTEM (K103133) | Depuy Spine, Inc. | 2011-01-18 |
| VIPER SYSTEM, EXPEDIUM SYSTEM (K101993) | Depuy Spine, Inc. | 2010-12-07 |