The following data is part of a premarket notification filed by Std Mfg., Inc. with the FDA for Contoured Articular Prosthesis (cap) Femoral Head Resurfacing System.
| Device ID | K021549 |
| 510k Number | K021549 |
| Device Name: | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 Stoughton, MA 02072 |
| Contact | Steve Ek |
| Correspondent | Steve Ek STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 Stoughton, MA 02072 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-13 |
| Decision Date | 2002-08-01 |
| Summary: | summary |