The following data is part of a premarket notification filed by Medacta International with the FDA for Mectacer Biolox Option Heads.
Device ID | K131518 |
510k Number | K131518 |
Device Name: | MECTACER BIOLOX OPTION HEADS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
Contact | Adam Gross |
Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-28 |
Decision Date | 2013-11-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630030809408 | K131518 | 000 |
07630030809392 | K131518 | 000 |
07630030809385 | K131518 | 000 |
07630030809378 | K131518 | 000 |
07630030809361 | K131518 | 000 |
07630030809354 | K131518 | 000 |
07630030809347 | K131518 | 000 |
07630030809330 | K131518 | 000 |
07630030809323 | K131518 | 000 |