The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Infinity Total Ankle System, Inbone Total Ankle System.
Device ID | K191393 |
510k Number | K191393 |
Device Name: | INFINITY Total Ankle System, INBONE Total Ankle System |
Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
Contact | Rachel Roberts |
Correspondent | Rachel Roberts Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
Product Code | HSN |
CFR Regulation Number | 888.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-24 |
Decision Date | 2019-08-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889797073097 | K191393 | 000 |
00889797072960 | K191393 | 000 |
00889797072977 | K191393 | 000 |
00889797072984 | K191393 | 000 |
00889797072991 | K191393 | 000 |
00889797073004 | K191393 | 000 |
00889797073011 | K191393 | 000 |
00889797073028 | K191393 | 000 |
00889797073035 | K191393 | 000 |
00889797073042 | K191393 | 000 |
00889797073059 | K191393 | 000 |
00889797073066 | K191393 | 000 |
00889797073073 | K191393 | 000 |
00889797073080 | K191393 | 000 |
00889797072953 | K191393 | 000 |