The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Poly-dial Inserts.
| Device ID | K924492 |
| 510k Number | K924492 |
| Device Name: | POLY-DIAL INSERTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Debrra L Bing |
| Correspondent | Debrra L Bing JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-03 |
| Decision Date | 1992-11-24 |