The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Apex Fixation Pins.
| Device ID | K011136 |
| 510k Number | K011136 |
| Device Name: | APEX FIXATION PINS |
| Classification | Pin, Fixation, Threaded |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327094633 | K011136 | 000 |
| 07613327073690 | K011136 | 000 |
| 07613327073706 | K011136 | 000 |
| 07613327074512 | K011136 | 000 |
| 07613327074536 | K011136 | 000 |
| 07613327074543 | K011136 | 000 |
| 07613327074550 | K011136 | 000 |
| 07613327074567 | K011136 | 000 |
| 07613327092011 | K011136 | 000 |
| 07613327092059 | K011136 | 000 |
| 07613327092073 | K011136 | 000 |
| 07613327094626 | K011136 | 000 |
| 07613327073683 | K011136 | 000 |