The following data is part of a premarket notification filed by Arthrotek/biomet, Inc. with the FDA for Washerloc Screw System, Ligament Screw System, No-profile Bi-cortical Screw System, Channel Ligament Clamp, Heckman Scre.
| Device ID | K981967 |
| 510k Number | K981967 |
| Device Name: | WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROTEK/BIOMET, INC. AIRPORT INDUSTRIAL PARK Warsaw, IN 46580 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres ARTHROTEK/BIOMET, INC. AIRPORT INDUSTRIAL PARK Warsaw, IN 46580 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-04 |
| Decision Date | 1998-07-17 |
| Summary: | summary |