The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Arcomxl Active Articulation.
Device ID | K110555 |
510k Number | K110555 |
Device Name: | ARCOMXL ACTIVE ARTICULATION |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
Contact | Bekcy Earl |
Correspondent | Bekcy Earl BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
Product Code | LPH |
Subsequent Product Code | KWY |
Subsequent Product Code | LZO |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-02-28 |
Decision Date | 2011-03-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304491434 | K110555 | 000 |
00880304527416 | K110555 | 000 |
00880304527386 | K110555 | 000 |
00880304527393 | K110555 | 000 |
00880304491328 | K110555 | 000 |
00880304491335 | K110555 | 000 |
00880304491342 | K110555 | 000 |
00880304491359 | K110555 | 000 |
00880304491366 | K110555 | 000 |
00880304491373 | K110555 | 000 |
00880304491380 | K110555 | 000 |
00880304491397 | K110555 | 000 |
00880304491403 | K110555 | 000 |
00880304491410 | K110555 | 000 |
00880304491427 | K110555 | 000 |
00880304527409 | K110555 | 000 |