| Device Classification Name |
Staple, Fixation, Bone
|
| 510(k) Number |
K953764 |
| Device Name |
LMT BONE ANCHOR |
| Applicant |
| Li Medical Technologies, Inc. |
| 4 Armstrong Rd. |
|
Shelton,
CT
06484
|
|
| Applicant Contact |
RHODEMANN LI |
| Correspondent |
| Li Medical Technologies, Inc. |
| 4 Armstrong Rd. |
|
Shelton,
CT
06484
|
|
| Correspondent Contact |
RHODEMANN LI |
| Regulation Number | 888.3030 |
| Classification Product Code |
|
| Date Received | 08/11/1995 |
| Decision Date | 08/25/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|