The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Anchors Away Soft Tissue Attachment System.
| Device ID | K952495 |
| 510k Number | K952495 |
| Device Name: | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 30031 AHERN AVE. Union City, CA 94587 -1234 |
| Contact | Steve Lamb |
| Correspondent | Steve Lamb ORTHOPEDIC SYSTEMS, INC. 30031 AHERN AVE. Union City, CA 94587 -1234 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-30 |
| Decision Date | 1996-01-22 |