The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Acromed Button Spinal Wire.
| Device ID | K895441 |
| 510k Number | K895441 |
| Device Name: | ACROMED BUTTON SPINAL WIRE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Zang, Rn |
| Correspondent | Zang, Rn ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-05 |
| Decision Date | 1989-11-22 |