The following data is part of a premarket notification filed by Lima Intl. Corp. with the FDA for Cl Hip Stem H/a Coated.
| Device ID | K922613 |
| 510k Number | K922613 |
| Device Name: | CL HIP STEM H/A COATED |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | LIMA INTL. CORP. 8021 KNUE ROAD, SUITE 121 Indianapolis, IN 46250 |
| Contact | Douglas Stuart |
| Correspondent | Douglas Stuart LIMA INTL. CORP. 8021 KNUE ROAD, SUITE 121 Indianapolis, IN 46250 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-02 |
| Decision Date | 1994-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051693300743 | K922613 | 000 |
| 05051693300736 | K922613 | 000 |
| 05051693300729 | K922613 | 000 |
| 05051693300712 | K922613 | 000 |
| 05051693300705 | K922613 | 000 |
| 05051693300699 | K922613 | 000 |