CHARITE ARTIFICIAL DISC
FDA premarket approval P040006/S002 · decided 2006-03-29
Approval details
- PMA number
- P040006
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CHARITE ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Depuy Spine, Inc.
- Date received
- 2005-02-22
- Decision date
- 2006-03-29
- Days to decision
- 400 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raynham, MA
- Statement
- APPROVAL FOR 1) NEW ENDPLATES COATED WITH VACUUM PLASMA-SPRAYED PURE TITANIUM AND CALCIUM PHOSPHATE; 2) THREE NEW INTERMEDIATE ENDPLATE SIZES UTILIZING THIS SAME COATING; AND 3) VARIOUS SURGICAL INSTRUMENTS TO ACCOMMODATE THE PROPOSED NEW ENDPLATES.
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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 |