The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Afs.
| Device ID | K032534 |
| 510k Number | K032534 |
| Device Name: | SYNTHES AFS |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | SYNTHES SPINE 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | John Walsh |
| Correspondent | John Walsh SYNTHES SPINE 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-15 |
| Decision Date | 2004-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98144710990 | K032534 | 000 |
| H981401388990 | K032534 | 000 |
| H981401386990 | K032534 | 000 |
| H981401362990 | K032534 | 000 |
| H981401360990 | K032534 | 000 |
| H981401358990 | K032534 | 000 |
| H981401356990 | K032534 | 000 |
| H981401354990 | K032534 | 000 |
| H981401138990 | K032534 | 000 |
| H981401136990 | K032534 | 000 |
| H981401390990 | K032534 | 000 |
| H981401392990 | K032534 | 000 |
| H9814431640 | K032534 | 000 |
| H9814431820 | K032534 | 000 |
| H9814431800 | K032534 | 000 |
| H9814431780 | K032534 | 000 |
| H9814431760 | K032534 | 000 |
| H9814431740 | K032534 | 000 |
| H9814431720 | K032534 | 000 |
| H9814431700 | K032534 | 000 |
| H9814431680 | K032534 | 000 |
| H9814431660 | K032534 | 000 |
| H981401134990 | K032534 | 000 |