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 |