The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Jet-x Tin Coated Half Pins.
Device ID | K023134 |
510k Number | K023134 |
Device Name: | JET-X TIN 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 | 2002-09-20 |
Decision Date | 2002-10-09 |
Summary: | summary |