The following data is part of a premarket notification filed by Plus Orthopedics Ag with the FDA for Ceramic Ball Heads, 28, 32 And 36 Mm.
| Device ID | K070928 |
| 510k Number | K070928 |
| Device Name: | CERAMIC BALL HEADS, 28, 32 AND 36 MM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk, MA 02056 |
| Contact | Pamela J Weagraff |
| Correspondent | Pamela J Weagraff PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk, MA 02056 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-03 |
| Decision Date | 2007-08-01 |
| Summary: | summary |