The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Intertan Chs Limited Collapse Set Screw.
| Device ID | K090656 |
| 510k Number | K090656 |
| Device Name: | INTERTAN CHS LIMITED COLLAPSE SET SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Shereen Myers |
| Correspondent | Shereen Myers SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-12 |
| Decision Date | 2009-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010614933 | K090656 | 000 |