The following data is part of a premarket notification filed by Alliance Partners, Llc with the FDA for Alamo C.
Device ID | K112361 |
510k Number | K112361 |
Device Name: | ALAMO C |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | ALLIANCE PARTNERS, LLC 33490 PIN OAK PARKWAY Avon Lake, OH 44012 |
Contact | Jennifer Palinchik |
Correspondent | Jennifer Palinchik ALLIANCE PARTNERS, LLC 33490 PIN OAK PARKWAY Avon Lake, OH 44012 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-17 |
Decision Date | 2011-11-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M6861412T4000 | K112361 | 000 |
M6861412T2140 | K112361 | 000 |
M6861412T2130 | K112361 | 000 |
M6861412T2120 | K112361 | 000 |
M6861412T2110 | K112361 | 000 |
M6861412T2100 | K112361 | 000 |
M6861412T2090 | K112361 | 000 |
M6861412T2080 | K112361 | 000 |
M6861412T2070 | K112361 | 000 |
M6861412T2060 | K112361 | 000 |
M6861412T2050 | K112361 | 000 |
M6861412T2040 | K112361 | 000 |
M6861412T2030 | K112361 | 000 |
M6861412T2020 | K112361 | 000 |
M6861412T2010 | K112361 | 000 |
M6861412T2150 | K112361 | 000 |
M6861412I0050 | K112361 | 000 |
M6861412I0060 | K112361 | 000 |
M6861412I7120 | K112361 | 000 |
M6861412I7110 | K112361 | 000 |
M6861412I7100 | K112361 | 000 |
M6861412I7090 | K112361 | 000 |
M6861412I7080 | K112361 | 000 |
M6861412I7070 | K112361 | 000 |
M6861412I7060 | K112361 | 000 |
M6861412I7050 | K112361 | 000 |
M6861412I0120 | K112361 | 000 |
M6861412I0110 | K112361 | 000 |
M6861412I0100 | K112361 | 000 |
M6861412I0090 | K112361 | 000 |
M6861412I0080 | K112361 | 000 |
M6861412I0070 | K112361 | 000 |
M6861412T2000 | K112361 | 000 |