The following data is part of a premarket notification filed by Simpex, Inc. with the FDA for Fixation Pin.
| Device ID | K911452 |
| 510k Number | K911452 |
| Device Name: | FIXATION PIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | SIMPEX, INC. 13775 SW LARCH PLACE, SUITE 26 Beaverton, OR 97005 |
| Contact | Richard Gorski |
| Correspondent | Richard Gorski SIMPEX, INC. 13775 SW LARCH PLACE, SUITE 26 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 | 1991-04-03 |
| Decision Date | 1991-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B068B125121 | K911452 | 000 |
| B068D1401 | K911452 | 000 |
| B068D140121 | K911452 | 000 |
| B068D14012S1 | K911452 | 000 |
| B068D140S1 | K911452 | 000 |
| B068D1561 | K911452 | 000 |
| B068D156121 | K911452 | 000 |
| B068D15612S1 | K911452 | 000 |
| B068D156S1 | K911452 | 000 |
| B068D1771 | K911452 | 000 |
| B068D177121 | K911452 | 000 |
| B068D17712S1 | K911452 | 000 |
| B068D177S1 | K911452 | 000 |
| B068D1871 | K911452 | 000 |
| B068D187121 | K911452 | 000 |
| B068D125S1 | K911452 | 000 |
| B068D12512S1 | K911452 | 000 |
| B068D0781 | K911452 | 000 |
| B068D078121 | K911452 | 000 |
| B068D07812S1 | K911452 | 000 |
| B068D078S1 | K911452 | 000 |
| B068D0931 | K911452 | 000 |
| B068D093121 | K911452 | 000 |
| B068D09312S1 | K911452 | 000 |
| B068D093S1 | K911452 | 000 |
| B068D1091 | K911452 | 000 |
| B068D109121 | K911452 | 000 |
| B068D10912S1 | K911452 | 000 |
| B068D109S1 | K911452 | 000 |
| B068D1251 | K911452 | 000 |
| B068D125121 | K911452 | 000 |
| B068D18712S1 | K911452 | 000 |
| B068D187S1 | K911452 | 000 |
| B068T0781 | K911452 | 000 |
| B068T140121 | K911452 | 000 |
| B068T14012S1 | K911452 | 000 |
| B068T140S1 | K911452 | 000 |
| B068T1561 | K911452 | 000 |
| B068T156121 | K911452 | 000 |
| B068T15612S1 | K911452 | 000 |
| B068T156S1 | K911452 | 000 |
| B068T1771 | K911452 | 000 |
| B068T177121 | K911452 | 000 |
| B068T17712S1 | K911452 | 000 |
| B068T177S1 | K911452 | 000 |
| B068T1871 | K911452 | 000 |
| B068T187121 | K911452 | 000 |
| B068T18712S1 | K911452 | 000 |
| B068T1401 | K911452 | 000 |
| B068T125S1 | K911452 | 000 |
| B068T078121 | K911452 | 000 |
| B068T07812S1 | K911452 | 000 |
| B068T078S1 | K911452 | 000 |
| B068T0931 | K911452 | 000 |
| B068T093121 | K911452 | 000 |
| B068T09312S1 | K911452 | 000 |
| B068T093S1 | K911452 | 000 |
| B068T1091 | K911452 | 000 |
| B068T109121 | K911452 | 000 |
| B068T10912S1 | K911452 | 000 |
| B068T109S1 | K911452 | 000 |
| B068T1251 | K911452 | 000 |
| B068T125121 | K911452 | 000 |
| B068T12512S1 | K911452 | 000 |
| B068T187S1 | K911452 | 000 |