The following data is part of a premarket notification filed by Orthopedic Sciences, Inc with the FDA for Tsy Shoulder Plate Implant.
| Device ID | K040850 |
| 510k Number | K040850 |
| Device Name: | TSY SHOULDER PLATE IMPLANT |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOPEDIC SCIENCES, INC 4329 GRAYDON RD. San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson ORTHOPEDIC SCIENCES, INC 4329 GRAYDON RD. San Diego, CA 92130 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-31 |
| Decision Date | 2004-06-24 |
| Summary: | summary |