The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Sagittal Saw Attachment.
| Device ID | K954483 |
| 510k Number | K954483 |
| Device Name: | STRYKER SAGITTAL SAW ATTACHMENT |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Tammy Lounds |
| Correspondent | Tammy Lounds STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1996-01-30 |