Apex Surgical, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Apex Surgical, LLC” (first 2000, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
Review panels
- Orthopedic (6)
Most recent Apex Surgical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043123 | APEX MODULAR HA HIP STEM | LPH | 2005-02-10 | 90 |
| K041950 | APEX K2 HIP SYSTEM | LPH | 2004-12-21 | 154 |
| K031110 | APEX MODULAR ACETABULAR CUP | LPH | 2003-05-22 | 44 |
| K012918 | APEX MODULAR ALUMINA FEMORAL HEAD | LZO | 2001-11-27 | 89 |
| K003923 | APEX MODULAR ZIRCONIA FEMORAL HEAD | LZO | 2001-03-20 | 90 |
| K000788 | APEX MODULAR HIP STEM | LPH | 2000-08-04 | 147 |
Recalls
6 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-01-17.
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.
- Apex Medical Corp. (36 510(k)s)
- Apex BioTechnology Corp. (35 510(k)s)
- Apex Dental Materials, Inc. (15 510(k)s)
- Apex Medical Technologies, Inc. (8 510(k)s)
- Apex Metal, Inc. (3 510(k)s)
- Apex Tools & Orthopedics Co. (2 510(k)s)
- Apex Ent., Inc. (1 510(k)s)
- Apex Imaging Corp. (1 510(k)s)
- Apex Medical Products, LLC (1 510(k)s)
- Apex Optical Ind. Co. (1 510(k)s)
- Apex Orthodontics, Inc. (1 510(k)s)
- Apex Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apex Surgical, LLC?
FDA lists 6 510(k) clearances under the applicant name “Apex Surgical, LLC” (first 2000, latest 2005), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Apex Surgical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apex Surgical, LLC is 90 days.
Which FDA product codes appear under Apex Surgical, LLC?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 4); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 2).
Next steps
- See all 6 Apex Surgical, LLC clearances with predicates and recalls
- Run predicate analysis for product code LPH, Apex Surgical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.