EBI DYNAFIX VS OSTEOTOMY SYSTEM
FDA 510(k) clearance K010551 · decided 2001-05-17
Clearance details
- K-number
- K010551
- Device name
- EBI DYNAFIX VS OSTEOTOMY SYSTEM
- Applicant
- Ebi, L.P.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-26
- Decision date
- 2001-05-17
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- NDF
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FR.O.H. CALCANEUS REPAIR SYSTEM (K051642) | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-08-22 |
| EBI DYNAFIX VS OSTEOTOMY SYSTEM (K021749) | Ebi, L.P. | 2002-08-12 |
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 |