The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Schultz Phalangeal Component Driver.
| Device ID | K870847 |
| 510k Number | K870847 |
| Device Name: | SCHULTZ PHALANGEAL COMPONENT DRIVER |
| Classification | Driver, Prosthesis |
| 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 | HWR |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-03-13 |