The following data is part of a premarket notification filed by United American Medical Co., Inc. with the FDA for Osteon Adaptor/cradle.
| Device ID | K930319 |
| 510k Number | K930319 |
| Device Name: | OSTEON ADAPTOR/CRADLE |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | UNITED AMERICAN MEDICAL CO., INC. 216 E. MAIN ST. P.O. BOX 308 Mc Minnville, TN 37110 |
| Contact | Thomas L Walling |
| Correspondent | Thomas L Walling UNITED AMERICAN MEDICAL CO., INC. 216 E. MAIN ST. P.O. BOX 308 Mc Minnville, TN 37110 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-22 |
| Decision Date | 1994-01-07 |