Alliance Partners, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Alliance Partners, LLC” (first 2011, latest 2020), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 126 |
| 2013 | 0 | — |
| 2014 | 3 | 74 |
| 2015 | 1 | 302 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 174 |
| 2019 | 0 | — |
| 2020 | 1 | 59 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alliance Partners, LLC took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
Review panels
- Orthopedic (8)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Alliance Partners, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201521 | Medina Anterior Cervical Plate System | KWQ | 2020-08-06 | 59 |
| K173128 | Alamo® C | ODP | 2018-03-22 | 174 |
| K141123 | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | GWO | 2015-02-27 | 302 |
| K141993 | NAKOMA ACP | KWQ | 2014-11-06 | 107 |
| K140303 | ALAMO T | MAX | 2014-04-21 | 74 |
| K133321 | ALAMO C | ODP | 2014-01-09 | 72 |
| K120401 | ALAMO T | MAX | 2012-10-05 | 240 |
| K122047 | ALAMO P | MAX | 2012-09-04 | 54 |
| K121181 | SWANNSHIDI BONE MARROW ASPIRATION NEEDLE | KNW | 2012-08-22 | 126 |
| K112361 | ALAMO C | ODP | 2011-11-30 | 105 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-06-09.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alliance Medical Corp. (47 510(k)s)
- Alliance Rubber Products Sdn. Bhd. (12 510(k)s)
- Alliance Global Technology Co., Ltd. (2 510(k)s)
- Alliance International Co., Ltd. (2 510(k)s)
- Alliance Pharmaceutical Corp. (2 510(k)s)
- Alliance Global (1 510(k)s)
- Alliance Instruments (1 510(k)s)
- Alliance Medical Marketinig (1 510(k)s)
- Alliance Tech Medical, Inc. (1 510(k)s)
- Alliance Medical Technologies, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alliance Partners, LLC?
FDA lists 10 510(k) clearances under the applicant name “Alliance Partners, LLC” (first 2011, latest 2020), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alliance Partners, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alliance Partners, LLC is 106 days.
Which FDA product codes appear under Alliance Partners, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 10 Alliance Partners, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Alliance Partners, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.