The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Cement Restrictor, Small And Large.
| Device ID | K021765 |
| 510k Number | K021765 |
| Device Name: | CEMENT RESTRICTOR, SMALL AND LARGE |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Gary Miller |
| Correspondent | Gary Miller EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-29 |
| Decision Date | 2002-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28031497000323 | K021765 | 000 |
| 08031497002842 | K021765 | 000 |