| Device Classification Name |
appliance, fixation, spinal interlaminal
|
|---|
| 510(K) Number |
K121877 |
|---|
| Model |
05-000-07-4506 THROUGH 05-000-07-4516, 05-000-24-0275, 05-002-02-0000, 05-008-00-0000 AND 05-008-01-0000
|
| Device Name |
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES |
|---|
| Applicant |
| EXACTECH, INC. |
| 2320 n.w. 66th ct. |
|
gainesville,
FL
32653
|
|
| Contact |
vladislava zaitseva |
| Regulation Number | 888.3050
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/28/2012 |
|---|
| Decision Date | 02/12/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
