The following data is part of a premarket notification filed by Ortho Development with the FDA for Ortho Devlopment Ceramic Femoral Head.
| Device ID | K111936 |
| 510k Number | K111936 |
| Device Name: | ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ORTHO DEVELOPMENT 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Contact | Tom Haueter |
| Correspondent | Tom Haueter ORTHO DEVELOPMENT 12187 S. BUSINESS PARK DR. Draper, UT 84020 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-08 |
| Decision Date | 2011-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409034963 | K111936 | 000 |
| 00822409034789 | K111936 | 000 |
| 00822409015870 | K111936 | 000 |
| 00822409015863 | K111936 | 000 |
| 00822409015856 | K111936 | 000 |
| 00822409015849 | K111936 | 000 |
| 00822409015801 | K111936 | 000 |
| 00822409015795 | K111936 | 000 |
| 00822409015788 | K111936 | 000 |
| 00822409015771 | K111936 | 000 |
| 00822409015733 | K111936 | 000 |
| 00822409015726 | K111936 | 000 |
| 00822409015719 | K111936 | 000 |
| 00822409015702 | K111936 | 000 |
| 00822409015665 | K111936 | 000 |
| 00822409015658 | K111936 | 000 |
| 00822409034796 | K111936 | 000 |
| 00822409034802 | K111936 | 000 |
| 00822409034956 | K111936 | 000 |
| 00822409034949 | K111936 | 000 |
| 00822409034932 | K111936 | 000 |
| 00822409034925 | K111936 | 000 |
| 00822409034918 | K111936 | 000 |
| 00822409034901 | K111936 | 000 |
| 00822409034895 | K111936 | 000 |
| 00822409034888 | K111936 | 000 |
| 00822409034871 | K111936 | 000 |
| 00822409034864 | K111936 | 000 |
| 00822409034857 | K111936 | 000 |
| 00822409034840 | K111936 | 000 |
| 00822409034833 | K111936 | 000 |
| 00822409034826 | K111936 | 000 |
| 00822409034819 | K111936 | 000 |
| 00822409015641 | K111936 | 000 |