The following data is part of a premarket notification filed by Mandell Horwitz Consultants Llc with the FDA for 2gc Hip/knee Modular Spacer.
| Device ID | K112470 |
| 510k Number | K112470 |
| Device Name: | 2GC HIP/KNEE MODULAR SPACER |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | MANDELL HORWITZ CONSULTANTS LLC 2995 STEVEN MARTIN DR Fairfax, VA 22031 |
| Contact | Diane M Horwitz |
| Correspondent | Diane M Horwitz MANDELL HORWITZ CONSULTANTS LLC 2995 STEVEN MARTIN DR Fairfax, VA 22031 |
| Product Code | KWL |
| Subsequent Product Code | JWH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | MBB |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-08-26 |
| Decision Date | 2012-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855195006500 | K112470 | 000 |
| 00855195006166 | K112470 | 000 |
| 00855195006159 | K112470 | 000 |
| 00855195006142 | K112470 | 000 |
| 00855195006135 | K112470 | 000 |
| 00855195006128 | K112470 | 000 |
| 00855195006111 | K112470 | 000 |
| 00855195006104 | K112470 | 000 |
| 00855195006098 | K112470 | 000 |
| 00855195006081 | K112470 | 000 |
| 00855195006074 | K112470 | 000 |
| 00855195006067 | K112470 | 000 |
| 00855195006050 | K112470 | 000 |
| 00855195006043 | K112470 | 000 |
| 00855195006036 | K112470 | 000 |
| 00855195006029 | K112470 | 000 |
| 00855195006012 | K112470 | 000 |
| 00855195006173 | K112470 | 000 |
| 00855195006258 | K112470 | 000 |
| 00855195006265 | K112470 | 000 |
| 00855195006425 | K112470 | 000 |
| 00855195006418 | K112470 | 000 |
| 00855195006401 | K112470 | 000 |
| 00855195006395 | K112470 | 000 |
| 00855195006388 | K112470 | 000 |
| 00855195006371 | K112470 | 000 |
| 00855195006364 | K112470 | 000 |
| 00855195006357 | K112470 | 000 |
| 00855195006340 | K112470 | 000 |
| 00855195006333 | K112470 | 000 |
| 00855195006326 | K112470 | 000 |
| 00855195006319 | K112470 | 000 |
| 00855195006302 | K112470 | 000 |
| 00855195006296 | K112470 | 000 |
| 00855195006289 | K112470 | 000 |
| 00855195006272 | K112470 | 000 |
| 00855195006005 | K112470 | 000 |