The following data is part of a premarket notification filed by Avec Scientific Design Corp. with the FDA for Chop Spine Frame.
| Device ID | K883295 |
| 510k Number | K883295 |
| Device Name: | CHOP SPINE FRAME |
| Classification | Surgical Table Cushion |
| Applicant | AVEC SCIENTIFIC DESIGN CORP. 7228 ELMWOOD AVE. Philadelphia, PA 19142 |
| Contact | Aaron Heintz |
| Correspondent | Aaron Heintz AVEC SCIENTIFIC DESIGN CORP. 7228 ELMWOOD AVE. Philadelphia, PA 19142 |
| Product Code | LWG |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-04 |
| Decision Date | 1988-08-23 |