The following data is part of a premarket notification filed by Alliance Partners, Llc with the FDA for Alamo T.
| Device ID | K120401 |
| 510k Number | K120401 |
| Device Name: | ALAMO T |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-08 |
| Decision Date | 2012-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6862811T10050 | K120401 | 000 |
| M6863211I0110 | K120401 | 000 |
| M6863211I0100 | K120401 | 000 |
| M6863211I0090 | K120401 | 000 |
| M6863211I0080 | K120401 | 000 |
| M6862811I0140 | K120401 | 000 |
| M6862811I0130 | K120401 | 000 |
| M6862811I0120 | K120401 | 000 |
| M6862811I0110 | K120401 | 000 |
| M6862811I0100 | K120401 | 000 |
| M6862811I0090 | K120401 | 000 |
| M6862811I0080 | K120401 | 000 |
| M6862811I0070 | K120401 | 000 |
| M6862811I0060 | K120401 | 000 |
| M6862100T13010 | K120401 | 000 |
| M6863211I0120 | K120401 | 000 |
| M6863211I0130 | K120401 | 000 |
| M6863211I0140 | K120401 | 000 |
| M6862811T10040 | K120401 | 000 |
| M6862100T19040 | K120401 | 000 |
| M6862100T11400 | K120401 | 000 |
| M6862100T11340 | K120401 | 000 |
| M6862100T11320 | K120401 | 000 |
| M6862100T11240 | K120401 | 000 |
| M6862100T11140 | K120401 | 000 |
| M6862100T11040 | K120401 | 000 |
| M6862100T11020 | K120401 | 000 |
| M6862100T10040 | K120401 | 000 |
| M6862100T10020 | K120401 | 000 |
| M6862100T14020 | K120401 | 000 |
| M6862100T14010 | K120401 | 000 |
| M6862100T14000 | K120401 | 000 |
| M6862100T13000 | K120401 | 000 |