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 |