The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Cross Round & Square Spinal Rods & Dist. Spinal.
| Device ID | K894472 |
| 510k Number | K894472 |
| Device Name: | CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | Bromm, R.n. |
| Correspondent | Bromm, R.n. BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-18 |
| Decision Date | 1989-10-10 |