The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Cemex System Gun Application Version.
| Device ID | K000943 |
| 510k Number | K000943 |
| Device Name: | CEMEX SYSTEM GUN APPLICATION VERSION |
| Classification | Bone Cement |
| 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 | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2001-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28031497000217 | K000943 | 000 |
| 28031497000132 | K000943 | 000 |