The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Rc Multisuture Bone Anchor, Model 4453/4454.
| Device ID | K992458 |
| 510k Number | K992458 |
| Device Name: | RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Contact | Kathleen Morahan |
| Correspondent | Kathleen Morahan INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-23 |
| Decision Date | 1999-10-14 |
| Summary: | summary |