Meditech Spine, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Meditech Spine, LLC” (first 2015, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Since 2017 the median was 80 days, against 98 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 2 | 194 |
| 2016 | 1 | 121 |
| 2017 | 2 | 68 |
| 2018 | 2 | 90 |
| 2019 | 0 | — |
| 2020 | 2 | 56 |
| 2021 | 1 | 44 |
| 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 Meditech Spine, LLC took a median 80 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 6 | 6 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Meditech Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) System | KWQ | 2021-03-18 | 44 |
| K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System | ODP | 2020-09-11 | 98 |
| K201136 | Cure Lumbar Plate System | KWQ | 2020-05-12 | 14 |
| K181543 | Cure OPEL-C Plate System | KWQ | 2018-08-31 | 80 |
| K180090 | Cure Lumbar Plate System | KWQ | 2018-04-23 | 101 |
| K171538 | Cure Lumbar Plate System | KWQ | 2017-06-16 | 21 |
| K170395 | Talos® Lumbar (HA) PEEK IBF Devices | MAX | 2017-06-02 | 114 |
| K160604 | Cure Anterior Cervical Plate (ACP) System | KWQ | 2016-07-01 | 121 |
| K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices | ODP | 2015-10-14 | 203 |
| K142345 | Talos-C(HA) Cervical Intervertebral Body Fusion Devices | ODP | 2015-02-22 | 184 |
Recalls
openFDA lists no recalls under a recalling firm named Meditech Spine, 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.
- Meditech International, Inc. (5 510(k)s)
- Meditech , Ltd. (3 510(k)s)
- Meditech Advisors, LLC (2 510(k)s)
- Meditech Gloves Sdn Bhd (2 510(k)s)
- Meditech Kft. (2 510(k)s)
- Meditech Endoscopy, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meditech Spine, LLC?
FDA lists 10 510(k) clearances under the applicant name “Meditech Spine, LLC” (first 2015, latest 2021), across 3 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 Meditech Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meditech Spine, LLC is 100 days. Since 2017: 80 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Meditech Spine, LLC?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 6); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 10 Meditech Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Meditech Spine, 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.