The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Sof'wire Titanium Cable System.
| Device ID | K923869 |
| 510k Number | K923869 |
| Device Name: | CODMAN SOF'WIRE TITANIUM CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Sally L Maher |
| Correspondent | Sally L Maher Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-03 |
| Decision Date | 1993-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034002286 | K923869 | 000 |
| 10705034002262 | K923869 | 000 |