The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Multi-use Compression Screw.
Device ID | K043102 |
510k Number | K043102 |
Device Name: | MULTI-USE COMPRESSION SCREW |
Classification | Screw, Fixation, Bone |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Wesley L Reed |
Correspondent | Wesley L Reed WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-09 |
Decision Date | 2005-01-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840420108661 | K043102 | 000 |
00840420108784 | K043102 | 000 |
00840420108791 | K043102 | 000 |
00840420108807 | K043102 | 000 |
00840420108814 | K043102 | 000 |
00840420108821 | K043102 | 000 |
00840420108838 | K043102 | 000 |
00840420108845 | K043102 | 000 |
00840420108852 | K043102 | 000 |
00840420108777 | K043102 | 000 |
00840420108760 | K043102 | 000 |
00840420108753 | K043102 | 000 |
00840420108678 | K043102 | 000 |
00840420108685 | K043102 | 000 |
00840420108692 | K043102 | 000 |
00840420108708 | K043102 | 000 |
00840420108715 | K043102 | 000 |
00840420108722 | K043102 | 000 |
00840420108739 | K043102 | 000 |
00840420108746 | K043102 | 000 |
00840420108869 | K043102 | 000 |
00840420108876 | K043102 | 000 |
00840420108999 | K043102 | 000 |
00840420109002 | K043102 | 000 |
00840420109019 | K043102 | 000 |
00840420109026 | K043102 | 000 |
00840420109033 | K043102 | 000 |
00840420109040 | K043102 | 000 |
00840420109057 | K043102 | 000 |
00840420109064 | K043102 | 000 |
00840420108982 | K043102 | 000 |
00840420108975 | K043102 | 000 |
00840420108968 | K043102 | 000 |
00840420108883 | K043102 | 000 |
00840420108890 | K043102 | 000 |
00840420108906 | K043102 | 000 |
00840420108913 | K043102 | 000 |
00840420108920 | K043102 | 000 |
00840420108937 | K043102 | 000 |
00840420108944 | K043102 | 000 |
00840420108951 | K043102 | 000 |
00840420109071 | K043102 | 000 |