The following data is part of a premarket notification filed by Alliance Partners, Llc with the FDA for Alamo P.
| Device ID | K122047 |
| 510k Number | K122047 |
| Device Name: | ALAMO P |
| 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 | 2012-07-12 |
| Decision Date | 2012-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6862811T10020 | K122047 | 000 |
| M6862210I7130 | K122047 | 000 |
| M6862210I7140 | K122047 | 000 |
| M6862510I0080 | K122047 | 000 |
| M6862510I0090 | K122047 | 000 |
| M6862510I0100 | K122047 | 000 |
| M6862510I0110 | K122047 | 000 |
| M6862510I0120 | K122047 | 000 |
| M6862510I0130 | K122047 | 000 |
| M6862210I7120 | K122047 | 000 |
| M6862210I7110 | K122047 | 000 |
| M6862210I0090 | K122047 | 000 |
| M6862210I0100 | K122047 | 000 |
| M6862210I0110 | K122047 | 000 |
| M6862210I0120 | K122047 | 000 |
| M6862210I0130 | K122047 | 000 |
| M6862210I0140 | K122047 | 000 |
| M6862210I7090 | K122047 | 000 |
| M6862210I7100 | K122047 | 000 |
| M6862510I0140 | K122047 | 000 |
| M6862510I7090 | K122047 | 000 |
| M6862810I0130 | K122047 | 000 |
| M6862810I0140 | K122047 | 000 |
| M6862810I7090 | K122047 | 000 |
| M6862810I7100 | K122047 | 000 |
| M6862810I7110 | K122047 | 000 |
| M6862810I7120 | K122047 | 000 |
| M6862810I7130 | K122047 | 000 |
| M6862810I7140 | K122047 | 000 |
| M6862810I0120 | K122047 | 000 |
| M6862810I0110 | K122047 | 000 |
| M6862510I7100 | K122047 | 000 |
| M6862510I7110 | K122047 | 000 |
| M6862510I7120 | K122047 | 000 |
| M6862510I7130 | K122047 | 000 |
| M6862510I7140 | K122047 | 000 |
| M6862810I0080 | K122047 | 000 |
| M6862810I0090 | K122047 | 000 |
| M6862810I0100 | K122047 | 000 |
| M6862210I0080 | K122047 | 000 |