The following data is part of a premarket notification filed by Axiom Orthopaedics, Inc. with the FDA for Axiom Orthopaedics Shoulder Resurfacing System.
| Device ID | K061862 |
| 510k Number | K061862 |
| Device Name: | AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | AXIOM ORTHOPAEDICS, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane AXIOM ORTHOPAEDICS, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-30 |
| Decision Date | 2006-08-28 |
| Summary: | summary |