The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Jet-x Ha Coated Half Pins.
Device ID | K023921 |
510k Number | K023921 |
Device Name: | JET-X HA COATED HALF PINS |
Classification | Pin, Fixation, Threaded |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | David Henley |
Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-25 |
Decision Date | 2003-02-05 |
Summary: | summary |