The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Harrington-type Instru-scoliosis.
| Device ID | K840423 |
| 510k Number | K840423 |
| Device Name: | HARRINGTON-TYPE INSTRU-SCOLIOSIS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | LINK AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-31 |
| Decision Date | 1984-03-23 |