The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Spacer G Temporary Hip Prosthesis.
| Device ID | K031841 |
| 510k Number | K031841 |
| Device Name: | SPACER G TEMPORARY HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Gary J Miller |
| Correspondent | Gary J Miller EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-06-16 |
| Decision Date | 2004-01-22 |
| Summary: | summary |