The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Radius Osteotomy Plates.
| Device ID | K914804 |
| 510k Number | K914804 |
| Device Name: | RADIUS OSTEOTOMY PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Contact | Mr. E Schussler |
| Correspondent | Mr. E Schussler LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-24 |
| Decision Date | 1992-04-29 |