The following data is part of a premarket notification filed by Thackray Usa with the FDA for Wroblewski Spring Compression Wire System.
| Device ID | K882890 |
| 510k Number | K882890 |
| Device Name: | WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke THACKRAY USA R.D. #3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-11 |
| Decision Date | 1988-08-08 |