The following data is part of a premarket notification filed by Lima Intl. Corp. with the FDA for Pgr Hip Stem (endoprosthesis) For Large Bone Resec.
| Device ID | K896851 |
| 510k Number | K896851 |
| Device Name: | PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence, RI 02915 |
| Contact | Pollonio-lister |
| Correspondent | Pollonio-lister LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence, RI 02915 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-05 |
| Decision Date | 1991-01-01 |