The following data is part of a premarket notification filed by Li Medical Technologies, Inc. with the FDA for Lm Bone Anchor (orthopedics).
| Device ID | K963812 |
| 510k Number | K963812 |
| Device Name: | LM BONE ANCHOR (ORTHOPEDICS) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD. Shelton, CT 06484 |
| Contact | Rhodeman Li |
| Correspondent | Rhodeman Li LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD. Shelton, CT 06484 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-09 |
| Decision Date | 1996-11-12 |
| Summary: | summary |