The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Linear Hip Stem, Size 5.
| Device ID | K120241 |
| 510k Number | K120241 |
| Device Name: | LINEAR HIP STEM, SIZE 5 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-27 |
| Decision Date | 2012-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912079051 | K120241 | 000 |
| 00888912078887 | K120241 | 000 |
| 00888912078870 | K120241 | 000 |
| 00888912078856 | K120241 | 000 |
| 00888912078849 | K120241 | 000 |
| 00888912078832 | K120241 | 000 |
| 00888912078825 | K120241 | 000 |
| 00888912078818 | K120241 | 000 |
| 00888912078801 | K120241 | 000 |
| 00888912078795 | K120241 | 000 |
| 00888912078788 | K120241 | 000 |
| 00888912078771 | K120241 | 000 |
| 00888912079006 | K120241 | 000 |
| 00888912078894 | K120241 | 000 |
| 00888912078900 | K120241 | 000 |
| 00888912078917 | K120241 | 000 |
| 00888912079044 | K120241 | 000 |
| 00888912079037 | K120241 | 000 |
| 00888912079020 | K120241 | 000 |
| 00888912079013 | K120241 | 000 |
| 00888912078993 | K120241 | 000 |
| 00888912078986 | K120241 | 000 |
| 00888912078979 | K120241 | 000 |
| 00888912078962 | K120241 | 000 |
| 00888912078955 | K120241 | 000 |
| 00888912078948 | K120241 | 000 |
| 00888912078931 | K120241 | 000 |
| 00888912078924 | K120241 | 000 |
| 00888912078863 | K120241 | 000 |