The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Memory Staple.
| Device ID | K061798 |
| 510k Number | K061798 |
| Device Name: | BIOPRO MEMORY STAPLE |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | David Mrak |
| Correspondent | David Mrak BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B56217781WB0 | K061798 | 000 |
| G0792001176360 | K061798 | 000 |
| G0792001176350 | K061798 | 000 |
| G0792001176340 | K061798 | 000 |
| G0792001176330 | K061798 | 000 |
| G0792001176320 | K061798 | 000 |
| G0792001176310 | K061798 | 000 |
| G0792001176300 | K061798 | 000 |
| G0792001176290 | K061798 | 000 |
| G0792001176280 | K061798 | 000 |
| G0792001176270 | K061798 | 000 |
| G0792001176260 | K061798 | 000 |
| G0792001176250 | K061798 | 000 |
| G0792001176240 | K061798 | 000 |
| G0792001176230 | K061798 | 000 |
| G0792001176220 | K061798 | 000 |
| M209227750 | K061798 | 000 |
| G0792001176370 | K061798 | 000 |
| G0792001176380 | K061798 | 000 |
| B56217638WB0 | K061798 | 000 |
| B56217637WB0 | K061798 | 000 |
| B56217636WB0 | K061798 | 000 |
| B56217635WB0 | K061798 | 000 |
| B56217634WB0 | K061798 | 000 |
| B56217633WB0 | K061798 | 000 |
| B56217632WB0 | K061798 | 000 |
| B56217631WB0 | K061798 | 000 |
| B56217630WB0 | K061798 | 000 |
| B56217629WB0 | K061798 | 000 |
| B56217628WB0 | K061798 | 000 |
| B56217627WB0 | K061798 | 000 |
| B56217626WB0 | K061798 | 000 |
| B56217625WB0 | K061798 | 000 |
| B56217624WB0 | K061798 | 000 |
| B56217623WB0 | K061798 | 000 |
| M209227740 | K061798 | 000 |
| M209192250 | K061798 | 000 |
| M209176340 | K061798 | 000 |
| M209176330 | K061798 | 000 |
| M209176320 | K061798 | 000 |
| M209176310 | K061798 | 000 |
| M209176300 | K061798 | 000 |
| M209176290 | K061798 | 000 |
| M209176280 | K061798 | 000 |
| M209176270 | K061798 | 000 |
| M209176260 | K061798 | 000 |
| M209176250 | K061798 | 000 |
| M209176240 | K061798 | 000 |
| M209176230 | K061798 | 000 |
| M209176220 | K061798 | 000 |
| G0792001227750 | K061798 | 000 |
| G0792001227740 | K061798 | 000 |
| G0792001177820 | K061798 | 000 |
| M209176350 | K061798 | 000 |
| M209176360 | K061798 | 000 |
| M209182640 | K061798 | 000 |
| M209182630 | K061798 | 000 |
| M209182620 | K061798 | 000 |
| M209182610 | K061798 | 000 |
| M209182600 | K061798 | 000 |
| M209182590 | K061798 | 000 |
| M209177820 | K061798 | 000 |
| M209177810 | K061798 | 000 |
| M209177200 | K061798 | 000 |
| M209177190 | K061798 | 000 |
| M209177180 | K061798 | 000 |
| M209177170 | K061798 | 000 |
| M209177160 | K061798 | 000 |
| M209177150 | K061798 | 000 |
| M209176380 | K061798 | 000 |
| M209176370 | K061798 | 000 |
| G0792001177810 | K061798 | 000 |
| 00841742101002 | K061798 | 000 |
| 00841742100814 | K061798 | 000 |
| 00841742100807 | K061798 | 000 |
| 00841742100791 | K061798 | 000 |
| 00841742100784 | K061798 | 000 |
| M209177080 | K061798 | 000 |
| M209177070 | K061798 | 000 |
| M209176620 | K061798 | 000 |
| M209176550 | K061798 | 000 |
| M209176540 | K061798 | 000 |
| M209176530 | K061798 | 000 |
| M209176520 | K061798 | 000 |
| M209176510 | K061798 | 000 |
| M20917651 | K061798 | 000 |
| M209176500 | K061798 | 000 |
| M209176490 | K061798 | 000 |
| M209176480 | K061798 | 000 |
| 00841742100821 | K061798 | 000 |
| 00841742100838 | K061798 | 000 |
| 00841742100999 | K061798 | 000 |
| 00841742100982 | K061798 | 000 |
| 00841742100975 | K061798 | 000 |
| 00841742100968 | K061798 | 000 |
| 00841742100951 | K061798 | 000 |
| 00841742100944 | K061798 | 000 |
| 00841742100937 | K061798 | 000 |
| 00841742100920 | K061798 | 000 |
| 00841742100913 | K061798 | 000 |
| 00841742100906 | K061798 | 000 |
| 00841742100890 | K061798 | 000 |
| 00841742100883 | K061798 | 000 |
| 00841742100876 | K061798 | 000 |
| 00841742100869 | K061798 | 000 |
| 00841742100852 | K061798 | 000 |
| 00841742100845 | K061798 | 000 |
| M209176470 | K061798 | 000 |
| M20917560 | K061798 | 000 |
| 00810012483865 | K061798 | 000 |
| 00810012483858 | K061798 | 000 |
| 00810012483841 | K061798 | 000 |
| 00810012483834 | K061798 | 000 |
| 00810012483827 | K061798 | 000 |
| 00810012483810 | K061798 | 000 |
| 00810012483803 | K061798 | 000 |
| 00810012483797 | K061798 | 000 |
| 00810012483780 | K061798 | 000 |
| 00810012483773 | K061798 | 000 |
| 00810012483766 | K061798 | 000 |
| 00810012483759 | K061798 | 000 |
| B56217622WB0 | K061798 | 000 |
| B56222775WB0 | K061798 | 000 |
| B56222774WB0 | K061798 | 000 |
| B56219225WB0 | K061798 | 000 |
| 00810012483872 | K061798 | 000 |
| 00810012480352 | K061798 | 000 |
| 00810012480512 | K061798 | 000 |
| 00810012480505 | K061798 | 000 |
| 00810012480499 | K061798 | 000 |
| 00810012480482 | K061798 | 000 |
| 00810012480475 | K061798 | 000 |
| 00810012480468 | K061798 | 000 |
| 00810012480451 | K061798 | 000 |
| 00810012480444 | K061798 | 000 |
| 00810012480437 | K061798 | 000 |
| 00810012480420 | K061798 | 000 |
| 00810012480413 | K061798 | 000 |
| 00810012480406 | K061798 | 000 |
| 00810012480390 | K061798 | 000 |
| 00810012480383 | K061798 | 000 |
| 00810012480376 | K061798 | 000 |
| 00810012480369 | K061798 | 000 |
| B56217782WB0 | K061798 | 000 |