The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Movation Knee System.
Device ID | K121727 |
510k Number | K121727 |
Device Name: | MOVATION KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
Contact | William Garzon |
Correspondent | William Garzon 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 | 2012-06-12 |
Decision Date | 2012-08-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00888912113267 | K121727 | 000 |
00888912112802 | K121727 | 000 |
00888912112796 | K121727 | 000 |
00888912112772 | K121727 | 000 |
00888912112758 | K121727 | 000 |
00888912112734 | K121727 | 000 |
00888912112642 | K121727 | 000 |
00888912112635 | K121727 | 000 |
00888912112628 | K121727 | 000 |
00888912112598 | K121727 | 000 |
00888912112574 | K121727 | 000 |
00888912112550 | K121727 | 000 |
00888912112451 | K121727 | 000 |
00888912112444 | K121727 | 000 |
00888912112437 | K121727 | 000 |
00888912112413 | K121727 | 000 |
00888912112390 | K121727 | 000 |
00888912112819 | K121727 | 000 |
00888912112901 | K121727 | 000 |
00888912113250 | K121727 | 000 |
00888912113243 | K121727 | 000 |
00888912113229 | K121727 | 000 |
00888912113205 | K121727 | 000 |
00888912113182 | K121727 | 000 |
00888912113151 | K121727 | 000 |
00888912113144 | K121727 | 000 |
00888912113137 | K121727 | 000 |
00888912113113 | K121727 | 000 |
00888912113090 | K121727 | 000 |
00888912113076 | K121727 | 000 |
00888912112987 | K121727 | 000 |
00888912112970 | K121727 | 000 |
00888912112963 | K121727 | 000 |
00888912112949 | K121727 | 000 |
00888912112925 | K121727 | 000 |
00888912112376 | K121727 | 000 |