5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
FDA 510(k) clearance K090203 · decided 2009-07-30
Clearance details
- K-number
- K090203
- Device name
- 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
- Applicant
- Ebi, L.P.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-27
- Decision date
- 2009-07-30
- Days to decision
- 184 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SCOLITRON(TM) STIMULATOR (P820008/S005) | Ebi, L.P. | 1987-04-02 |
| SCOLITRON(TM) STIMULATOR (P820008/S004) | Ebi, L.P. | 1987-01-07 |
| SCOLITRON(TM) STIMULATOR (P820008/S003) | Ebi, L.P. | 1986-09-12 |
| SCOLITRON(TM) STIMULATOR (P820008/S002) | Ebi, L.P. | 1986-01-17 |
| SCOLITRON(TM) STIMULATOR (P820008/S001) | Ebi, L.P. | 1983-06-14 |
| SCOLITRON(TM) STIMULATOR (P820008) | Ebi, L.P. | 1983-01-06 |