The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Orthopedics Saw Blade.
| Device ID | K931210 |
| 510k Number | K931210 |
| Device Name: | INTERMEDICS ORTHOPEDICS SAW BLADE |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Joann Ringer |
| Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-10 |
| Decision Date | 1993-11-18 |