| Device Classification Name |
Arthroscope
|
| 510(k) Number |
K252666 |
| Device Name |
Articulator Arthroscopic Bur |
| Applicant |
| Joint Preservation Innovations, LLC |
| 115 E. Ogden Ave. |
| Suite 105-323 |
|
Naperville,
IL
60563
|
|
| Applicant Contact |
Sanjeev Bhatia |
| Correspondent |
| Medical Device Academy |
| 345 |
| Lincoln Hill Rd. |
|
Shrewsbury,
VT
05738
|
|
| Correspondent Contact |
Rob Packard |
| Regulation Number | 888.1100 |
| Classification Product Code |
|
| Date Received | 08/25/2025 |
| Decision Date | 11/21/2025 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|