The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Rebel 3dknee System.
| Device ID | K143242 |
| 510k Number | K143242 |
| Device Name: | Rebel 3DKNEE System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto ENCORE MEDICAL, L.P. 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 | 2014-11-12 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446736080 | K143242 | 000 |
| 00190446736165 | K143242 | 000 |
| 00190446735762 | K143242 | 000 |
| 00190446735779 | K143242 | 000 |
| 00190446735786 | K143242 | 000 |
| 00190446735793 | K143242 | 000 |
| 00190446735854 | K143242 | 000 |
| 00190446735861 | K143242 | 000 |
| 00190446735878 | K143242 | 000 |
| 00190446736158 | K143242 | 000 |
| 00190446736141 | K143242 | 000 |
| 00190446735823 | K143242 | 000 |
| 00190446735830 | K143242 | 000 |
| 00190446735847 | K143242 | 000 |
| 00190446736097 | K143242 | 000 |
| 00190446736103 | K143242 | 000 |
| 00190446736110 | K143242 | 000 |
| 00190446736127 | K143242 | 000 |
| 00190446736134 | K143242 | 000 |
| 00190446735885 | K143242 | 000 |
| 00190446735892 | K143242 | 000 |
| 00190446736004 | K143242 | 000 |
| 00190446736011 | K143242 | 000 |
| 00190446736028 | K143242 | 000 |
| 00190446736035 | K143242 | 000 |
| 00190446736042 | K143242 | 000 |
| 00190446736059 | K143242 | 000 |
| 00190446736066 | K143242 | 000 |
| 00190446736073 | K143242 | 000 |
| 00190446735991 | K143242 | 000 |
| 00190446735984 | K143242 | 000 |
| 00190446735908 | K143242 | 000 |
| 00190446735915 | K143242 | 000 |
| 00190446735922 | K143242 | 000 |
| 00190446735939 | K143242 | 000 |
| 00190446735946 | K143242 | 000 |
| 00190446735953 | K143242 | 000 |
| 00190446735960 | K143242 | 000 |
| 00190446735977 | K143242 | 000 |
| 00190446735816 | K143242 | 000 |