| Device Classification Name |
Screw, Fixation, Bone
|
|---|
| 510(k) Number |
K101030 |
|---|
| Device Name |
MODIFICATION TO HBS HEADLESS BONE SCREW |
|---|
| Applicant |
| Biopro, Inc. |
| 2929 Lapeer Rd. |
|
Port Huron,
MI
48060
|
|
| Applicant Contact |
DAVID MRAK |
| Correspondent |
| Biopro, Inc. |
| 2929 Lapeer Rd. |
|
Port Huron,
MI
48060
|
|
| Correspondent Contact |
DAVID MRAK |
| Regulation Number | 888.3040 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/13/2010 |
|---|
| Decision Date | 06/03/2010 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Orthopedic
|
|---|
| 510k Review Panel |
Orthopedic
|
|---|
| Summary |
Summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
| Recalls |
CDRH Recalls
|
|---|