The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-peg Patella Highly Cross Linked Ve Metal Backed Pa.
| Device ID | K113756 |
| 510k Number | K113756 |
| Device Name: | HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| 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 | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-21 |
| Decision Date | 2012-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912108881 | K113756 | 000 |
| 00888912108553 | K113756 | 000 |
| 00888912108539 | K113756 | 000 |
| 00888912108522 | K113756 | 000 |
| 00888912108515 | K113756 | 000 |
| 00888912108447 | K113756 | 000 |
| 00888912108430 | K113756 | 000 |
| 00888912108416 | K113756 | 000 |
| 00888912108409 | K113756 | 000 |
| 00888912108560 | K113756 | 000 |
| 00888912108676 | K113756 | 000 |
| 00888912108874 | K113756 | 000 |
| 00888912108850 | K113756 | 000 |
| 00888912108843 | K113756 | 000 |
| 00888912108836 | K113756 | 000 |
| 00888912108720 | K113756 | 000 |
| 00888912108713 | K113756 | 000 |
| 00888912108690 | K113756 | 000 |
| 00888912108683 | K113756 | 000 |
| 00888912108393 | K113756 | 000 |