The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Framelock; Framelock Accessories.
| Device ID | K022370 |
| 510k Number | K022370 |
| Device Name: | FRAMELOCK; FRAMELOCK ACCESSORIES |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | B.l. Mcdermott |
| Correspondent | B.l. Mcdermott MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-22 |
| Decision Date | 2002-10-18 |
| Summary: | summary |