EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
FDA 510(k) clearance K062494 · decided 2006-10-19
Clearance details
- K-number
- K062494
- Device name
- EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
- Applicant
- Ebi, L.P.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-25
- Decision date
- 2006-10-19
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, recall (Z-1439-2012) | Biomet, Inc. | 2012-04-19 |
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 |