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 |