The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acumed Tension Band Pin.
Device ID | K964500 |
510k Number | K964500 |
Device Name: | ACUMED TENSION BAND PIN |
Classification | Pin, Fixation, Smooth |
Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Contact | Shari L Jeffers |
Correspondent | Shari L Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-08 |
Decision Date | 1996-12-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10806378089794 | K964500 | 000 |
10806378085451 | K964500 | 000 |
10806378085475 | K964500 | 000 |
10806378085499 | K964500 | 000 |
10806378015700 | K964500 | 000 |
10806378015717 | K964500 | 000 |
10806378015724 | K964500 | 000 |
10806378015731 | K964500 | 000 |
10806378015748 | K964500 | 000 |
10806378015755 | K964500 | 000 |
10806378042003 | K964500 | 000 |
10806378088131 | K964500 | 000 |
10806378088148 | K964500 | 000 |
10806378088155 | K964500 | 000 |
10806378089763 | K964500 | 000 |
10806378089770 | K964500 | 000 |
10806378089787 | K964500 | 000 |
10806378085437 | K964500 | 000 |