The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Modification To Jet-x Ha Coated Half Pins.
| Device ID | K033289 |
| 510k Number | K033289 |
| Device Name: | MODIFICATION TO JET-X HA COATED HALF PINS |
| Classification | Pin, Fixation, Threaded |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2004-01-13 |
| Summary: | summary |