The following data is part of a premarket notification filed by Poly-medics,inc. with the FDA for Lactosorb Trauma Plating System.
| Device ID | K955729 |
| 510k Number | K955729 |
| Device Name: | LACTOSORB TRAUMA PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | POLY-MEDICS,INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary Verstynen POLY-MEDICS,INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-18 |
| Decision Date | 1996-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036195441 | K955729 | 000 |
| 00841036054526 | K955729 | 000 |
| 00841036054533 | K955729 | 000 |
| 00841036054557 | K955729 | 000 |
| 00841036054564 | K955729 | 000 |
| 00841036054588 | K955729 | 000 |
| 00841036054595 | K955729 | 000 |
| 00841036054601 | K955729 | 000 |
| 00841036054618 | K955729 | 000 |
| 00841036054519 | K955729 | 000 |
| 00841036054496 | K955729 | 000 |
| 00888233025300 | K955729 | 000 |
| 00841036052812 | K955729 | 000 |
| 00841036054380 | K955729 | 000 |
| 00841036054397 | K955729 | 000 |
| 00841036054410 | K955729 | 000 |
| 00841036054434 | K955729 | 000 |
| 00841036054458 | K955729 | 000 |
| 00841036054472 | K955729 | 000 |
| 00841036055431 | K955729 | 000 |
| 00841036055455 | K955729 | 000 |
| 00841036055608 | K955729 | 000 |
| 00841036055615 | K955729 | 000 |
| 00841036055639 | K955729 | 000 |
| 00841036055646 | K955729 | 000 |
| 00841036055653 | K955729 | 000 |
| 00841036055677 | K955729 | 000 |
| 00841036055707 | K955729 | 000 |
| 00841036195311 | K955729 | 000 |
| 00841036055585 | K955729 | 000 |
| 00841036055578 | K955729 | 000 |
| 00841036055462 | K955729 | 000 |
| 00841036055479 | K955729 | 000 |
| 00841036055493 | K955729 | 000 |
| 00841036055509 | K955729 | 000 |
| 00841036055523 | K955729 | 000 |
| 00841036055530 | K955729 | 000 |
| 00841036055547 | K955729 | 000 |
| 00841036055554 | K955729 | 000 |
| 00888233025294 | K955729 | 000 |