| Device Classification Name |
Orthopedic Stereotaxic Instrument
|
|---|
| 510(k) Number |
K100599 |
|---|
| Device Name |
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM |
|---|
| Applicant |
| Orthosoft, Inc. |
| 75 Queen St., Suite 3300 |
|
Montreal,
CA
H3C 2N6
|
|
| Applicant Contact |
CHRISTOPHER MCLEAN |
| Correspondent |
| Orthosoft, Inc. |
| 75 Queen St., Suite 3300 |
|
Montreal,
CA
H3C 2N6
|
|
| Correspondent Contact |
CHRISTOPHER MCLEAN |
| Regulation Number | 882.4560 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/03/2010 |
|---|
| Decision Date | 04/05/2010 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Neurology
|
|---|
| 510k Review Panel |
Orthopedic
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|