Ortho Tec, LLC: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Ortho Tec, LLC” (first 1999, latest 2004), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 9 | 9 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 6 | 6 |
| MNI | Orthosis, Spinal Pedicle Fixation | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Review panels
- Orthopedic (22)
Most recent Ortho Tec, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040514 | EOVIA CALCIUM PHOSPHATE CERAMIC | MQV | 2004-05-03 | 66 |
| K040346 | MODIFICATION TO ORIA TOP CLIP SYSTEM | MNI | 2004-03-12 | 29 |
| K030958 | ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS | MNI | 2003-11-20 | 238 |
| K031471 | ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 | KWP | 2003-10-10 | 154 |
| K023884 | MODIFICATION ORIA SPINAL SYSTEM | KWP | 2003-08-20 | 272 |
| K023378 | ORIA CLARIS | MNH | 2003-06-27 | 262 |
| K031452 | ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 | KWP | 2003-06-18 | 42 |
| K030500 | ORIA ZENITH | KWQ | 2003-03-20 | 29 |
| K023377 | ORIA CERVICAL PLATES | KWQ | 2003-03-04 | 147 |
| K030253 | ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | KWP | 2003-02-21 | 28 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ortho Tec, LLC.
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.
- Ortho Diagnostic Systems, Inc. (126 510(k)s)
- Ortho Development Corp. (64 510(k)s)
- Ortho Diagnostics, Inc. (24 510(k)s)
- Ortho Clinical Diagnostics (16 510(k)s)
- Ortho Pharmaceutical Corp. (9 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Organizers, Inc. (8 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Instruments (6 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
- Ortho Pared Instruments, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho Tec, LLC?
FDA lists 22 510(k) clearances under the applicant name “Ortho Tec, LLC” (first 1999, latest 2004), across 5 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 Ortho Tec, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Tec, LLC is 78 days.
Which FDA product codes appear under Ortho Tec, LLC?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 9); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 6); MNI (Orthosis, Spinal Pedicle Fixation, 4).
Next steps
- See all 22 Ortho Tec, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWP, Ortho Tec, 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.