CHARITE ARTIFICIAL DISC
FDA premarket approval P040006/S001 · decided 2005-06-16
Approval details
- PMA number
- P040006
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- CHARITE ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Depuy Spine, Inc.
- Date received
- 2005-01-07
- Decision date
- 2005-06-16
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raynham, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITES LOCATED AT DEPUY (IRELAND) LTD, CORK, IRELAND, FOR MANUFACTURING AND ISOTRON PLC, MARCUS CLOSE, BERKSHIRE, UNITED KINGDOM, FOR STERILIZATION.
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 |