The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Lateral Pivot Insert.
| Device ID | K000590 |
| 510k Number | K000590 |
| Device Name: | LATERAL PIVOT INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-21 |
| Decision Date | 2000-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912118088 | K000590 | 000 |
| 00888912117890 | K000590 | 000 |
| 00888912117883 | K000590 | 000 |
| 00888912117876 | K000590 | 000 |
| 00888912117852 | K000590 | 000 |
| 00888912117838 | K000590 | 000 |
| 00888912117821 | K000590 | 000 |
| 00888912117814 | K000590 | 000 |
| 00888912117784 | K000590 | 000 |
| 00888912117777 | K000590 | 000 |
| 00888912117760 | K000590 | 000 |
| 00888912117746 | K000590 | 000 |
| 00888912117722 | K000590 | 000 |
| 00888912117715 | K000590 | 000 |
| 00888912117708 | K000590 | 000 |
| 00888912023290 | K000590 | 000 |
| 00888912117906 | K000590 | 000 |
| 00888912117913 | K000590 | 000 |
| 00888912117920 | K000590 | 000 |
| 00888912118071 | K000590 | 000 |
| 00888912118064 | K000590 | 000 |
| 00888912118057 | K000590 | 000 |
| 00888912118040 | K000590 | 000 |
| 00888912118033 | K000590 | 000 |
| 00888912118026 | K000590 | 000 |
| 00888912118019 | K000590 | 000 |
| 00888912118002 | K000590 | 000 |
| 00888912117999 | K000590 | 000 |
| 00888912117982 | K000590 | 000 |
| 00888912117975 | K000590 | 000 |
| 00888912117968 | K000590 | 000 |
| 00888912117951 | K000590 | 000 |
| 00888912117944 | K000590 | 000 |
| 00888912117937 | K000590 | 000 |
| 00888912023283 | K000590 | 000 |