The following data is part of a premarket notification filed by Lima Intl. Corp. with the FDA for Lima Collared Cl Stem.
| Device ID | K910836 |
| 510k Number | K910836 |
| Device Name: | LIMA COLLARED CL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | LIMA INTL. CORP. 407 LINCOLN RD, SUITE 10L Miami Beach, FL 33139 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart LIMA INTL. CORP. 407 LINCOLN RD, SUITE 10L Miami Beach, FL 33139 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-27 |
| Decision Date | 1991-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051693300682 | K910836 | 000 |
| 05051693300583 | K910836 | 000 |
| 05051693300590 | K910836 | 000 |
| 05051693300606 | K910836 | 000 |
| 05051693300613 | K910836 | 000 |
| 05051693300620 | K910836 | 000 |
| 05051693300637 | K910836 | 000 |
| 05051693300644 | K910836 | 000 |
| 05051693300651 | K910836 | 000 |
| 05051693300668 | K910836 | 000 |
| 05051693300675 | K910836 | 000 |
| 05051693300576 | K910836 | 000 |