The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Threaded Pin, Self Drilling.
Device ID | K781251 |
510k Number | K781251 |
Device Name: | THREADED PIN, SELF DRILLING |
Classification | Pin, Fixation, Threaded |
Applicant | ACE ORTHOPEDIC MANUFACTURING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-21 |
Decision Date | 1978-08-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304546394 | K781251 | 000 |
00887868072598 | K781251 | 000 |
00887868072581 | K781251 | 000 |
00887868072512 | K781251 | 000 |
00887868070563 | K781251 | 000 |