SCOLITRON(TM) STIMULATOR
FDA premarket approval P820008/S003 · decided 1986-09-12
Approval details
- PMA number
- P820008
- Supplement
- S003
- Trade name
- SCOLITRON(TM) STIMULATOR
- Generic name
- Stimulator, functional neuromuscular, scoliosis
- Applicant
- Ebi, L.P.
- Date received
- 1985-07-01
- Decision date
- 1986-09-12
- Days to decision
- 438 days
- Decision code
- APPR
- Product code
- LWB
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Parsippany, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM (K100438) | Ebi, L.P. | 2010-06-23 |
| POLARIS SPINAL SYSTEM (K100220) | Ebi, L.P. | 2010-05-17 |
| PEANUT GROWTH CONTROL PLATING SYSTEM (K093880) | Ebi, L.P. | 2010-04-16 |
| ESL SPINAL SYSTEM (K092574) | Ebi, L.P. | 2010-02-04 |
| BIOMET VISION FOOTRING SYSTEM (K093057) | Ebi, L.P. | 2009-12-01 |
| C-THRU SPINAL SYSTEM (K092336) | Ebi, L.P. | 2009-10-15 |
| IBEX SPINAL SYSTEM (K091381) | Ebi, L.P. | 2009-08-07 |
| 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS (K090203) | Ebi, L.P. | 2009-07-30 |