The following data is part of a premarket notification filed by Orthopaedic Biosystems with the FDA for Xanchor Suture Attachment Device.
| Device ID | K932041 |
| 510k Number | K932041 |
| Device Name: | XANCHOR SUTURE ATTACHMENT DEVICE |
| Classification | Staple, Fixation, Bone |
| Applicant | ORTHOPAEDIC BIOSYSTEMS 736 N. COUNTRY CLUB DR. Mesa, AZ 85201 |
| Contact | Kerry Zang |
| Correspondent | Kerry Zang ORTHOPAEDIC BIOSYSTEMS 736 N. COUNTRY CLUB DR. Mesa, AZ 85201 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-27 |
| Decision Date | 1994-08-12 |