The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Domed Tri-peg Patella, Highly Cross Linked Domed Tri-peg Patella With Ve.
| Device ID | K121835 |
| 510k Number | K121835 |
| Device Name: | DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Michaela Norris |
| Correspondent | Michaela Norris ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-22 |
| Decision Date | 2012-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912253352 | K121835 | 000 |
| 00888912253345 | K121835 | 000 |
| 00888912253338 | K121835 | 000 |
| 00888912253321 | K121835 | 000 |
| 00888912253314 | K121835 | 000 |
| 00190446639268 | K121835 | 000 |