The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Mastersl Femoral Stem.
| Device ID | K140975 |
| 510k Number | K140975 |
| Device Name: | MASTERSL FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne, IN 46814 |
| Contact | Stephen Peoples |
| Correspondent | Stephen Peoples LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne, IN 46814 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-16 |
| Decision Date | 2014-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390084543 | K140975 | 000 |
| 08033390197786 | K140975 | 000 |
| 08033390197779 | K140975 | 000 |
| 08033390197762 | K140975 | 000 |
| 08033390197755 | K140975 | 000 |
| 08033390197748 | K140975 | 000 |
| 08033390197731 | K140975 | 000 |
| 08033390197724 | K140975 | 000 |
| 08033390197717 | K140975 | 000 |
| 08033390197700 | K140975 | 000 |
| 08033390197694 | K140975 | 000 |
| 08033390197687 | K140975 | 000 |
| 08033390197670 | K140975 | 000 |
| 08033390085304 | K140975 | 000 |
| 08033390104203 | K140975 | 000 |
| 08033390098311 | K140975 | 000 |
| 08033390083386 | K140975 | 000 |
| 08033390197793 | K140975 | 000 |
| 08033390082914 | K140975 | 000 |
| 08033390082921 | K140975 | 000 |
| 08033390090735 | K140975 | 000 |
| 08033390090728 | K140975 | 000 |
| 08033390083966 | K140975 | 000 |
| 08033390083959 | K140975 | 000 |
| 08033390083942 | K140975 | 000 |
| 08033390083034 | K140975 | 000 |
| 08033390083027 | K140975 | 000 |
| 08033390083010 | K140975 | 000 |
| 08033390083003 | K140975 | 000 |
| 08033390082990 | K140975 | 000 |
| 08033390082983 | K140975 | 000 |
| 08033390082976 | K140975 | 000 |
| 08033390082969 | K140975 | 000 |
| 08033390082952 | K140975 | 000 |
| 08033390082945 | K140975 | 000 |
| 08033390082938 | K140975 | 000 |
| 08033390024891 | K140975 | 000 |