The following data is part of a premarket notification filed by Biomet Trauma (aka Ebi Llc) with the FDA for Mac Male Adapter.
| Device ID | K102843 |
| 510k Number | K102843 |
| Device Name: | MAC MALE ADAPTER |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | BIOMET TRAUMA (AKA EBI LLC) 100 INTERPACE PARKWAY Parisppany, NJ 07054 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe BIOMET TRAUMA (AKA EBI LLC) 100 INTERPACE PARKWAY Parisppany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304591905 | K102843 | 000 |