The following data is part of a premarket notification filed by Stelkast Company with the FDA for Exp Acetabular Liner, Models Sc3342 Non-hooded 28mm, Sc3343 Hooded 28mm.
| Device ID | K094035 |
| 510k Number | K094035 |
| Device Name: | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
| Applicant | STELKAST COMPANY 200 HIDDEN VALLEY RD. Mcmurray, PA 15317 |
| Contact | Donald A Stevens |
| Correspondent | Donald A Stevens STELKAST COMPANY 200 HIDDEN VALLEY RD. Mcmurray, PA 15317 |
| Product Code | OQG |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MAY |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-30 |
| Decision Date | 2011-03-24 |
| Summary: | summary |