The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Litwin Cruicate Anchor.
| Device ID | K002600 |
| 510k Number | K002600 |
| Device Name: | LITWIN CRUICATE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Contact | Lanny L Johnson |
| Correspondent | Lanny L Johnson INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-21 |
| Decision Date | 2000-11-15 |