Core Essence Orthopaedics, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under 2 spellings of the applicant name “Core Essence Orthopaedics, Inc.” (first 2009, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 143 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
Review panels
Most recent Core Essence Orthopaedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111716 | KNOTLESS SUTURE FIXATION SYSTEM | MBI | 2011-11-10 | 143 |
| K101126 | PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS | MBI | 2010-12-02 | 224 |
| K090128 | TAC-TITE (TM) | GAT | 2009-03-19 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Core Essence Orthopaedics, Inc..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Core Essence Orthopaedics, Inc. (2)
- Core Essence Orthopaedics (1)
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.
- Core-Vent Corp. (25 510(k)s)
- Core Dynamics, Inc. (23 510(k)s)
- Core Essence Orthopaedics, LLC (3 510(k)s)
- Core-M, Inc. (3 510(k)s)
- Core Medical, Inc. (3 510(k)s)
- Core-Nexus (2 510(k)s)
- Core 3D Protech, S.L. (1 510(k)s)
- Core Access Surgical Technologies, Inc. (1 510(k)s)
- Core Healthcare , Ltd. (1 510(k)s)
- Core-M, L.P. (1 510(k)s)
- Core Scientific Creation , Ltd. (1 510(k)s)
- Core Scientific , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Core Essence Orthopaedics, Inc.?
FDA lists 3 510(k) clearances under 2 spellings of the applicant name “Core Essence Orthopaedics, Inc.” (first 2009, latest 2011), across 2 product codes in 2 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 Core Essence Orthopaedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Core Essence Orthopaedics, Inc. is 143 days.
Which FDA product codes appear under Core Essence Orthopaedics, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 1).
Next steps
- See all 3 Core Essence Orthopaedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Core Essence Orthopaedics, Inc.'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.