The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Attune® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, And Medialized Anatomic Patella With Affixium™ 3dp Technology.
Device ID | K202194 |
510k Number | K202194 |
Device Name: | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, And Medialized Anatomic Patella With AFFIXIUM™ 3DP Technology |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
Applicant | DePuy Ireland UC Loughbeg Ringaskiddy Co. Cork, IE |
Contact | Erin Combs |
Correspondent | Kathy Boggs DePuy Orthopaedic, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
Product Code | MBH |
CFR Regulation Number | 888.3565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-05 |
Decision Date | 2020-11-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295523789 | K202194 | 000 |
10603295507406 | K202194 | 000 |
10603295507413 | K202194 | 000 |
10603295507420 | K202194 | 000 |
10603295507437 | K202194 | 000 |
10603295507444 | K202194 | 000 |
10603295507451 | K202194 | 000 |
10603295507468 | K202194 | 000 |
10603295507475 | K202194 | 000 |
10603295507482 | K202194 | 000 |
10603295523604 | K202194 | 000 |
10603295523611 | K202194 | 000 |
10603295523628 | K202194 | 000 |
10603295523635 | K202194 | 000 |
10603295523758 | K202194 | 000 |
10603295523765 | K202194 | 000 |
10603295523772 | K202194 | 000 |
10603295507390 | K202194 | 000 |
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