The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Warsaw Orthopedic I Bone Plate.
| Device ID | K870727 |
| 510k Number | K870727 |
| Device Name: | WARSAW ORTHOPEDIC I BONE PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
| Contact | James Ritter |
| Correspondent | James Ritter WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-24 |
| Decision Date | 1987-03-09 |