Tyber Medical, LLC: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Tyber Medical, LLC” (first 2013, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 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 |
|---|---|---|
| 2013 | 1 | 210 |
| 2014 | 1 | 92 |
| 2015 | 2 | 91 |
| 2016 | 2 | 116 |
| 2017 | 3 | 113 |
| 2018 | 1 | 122 |
| 2019 | 1 | 148 |
| 2020 | 3 | 76 |
| 2021 | 1 | 227 |
| 2022 | 1 | 107 |
| 2023 | 6 | 90 |
| 2024 | 1 | 30 |
| 2025 | 4 | 100 |
| 2026 | 4 | 75 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tyber Medical, LLC took a median 90 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 11 | 11 |
| HWC | Screw, Fixation, Bone | 9 | 9 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 2 |
| PLF | Bone Wedge | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Review panels
- Orthopedic (31)
Most recent Tyber Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261207 | Exalta Proximal Tibia Plating System | HRS | 2026-06-12 | 60 |
| K260810 | Anteralign LS coverplate | OVD | 2026-06-10 | 90 |
| K261060 | Navigated LLIF Impactable Tracker | OLO | 2026-05-29 | 59 |
| K253042 | Tyber Medical Trauma Screw | HWC | 2026-04-03 | 193 |
| K252901 | Tyber Medical Trauma Screw | HWC | 2025-12-31 | 111 |
| K252742 | Navigated Instruments | OLO | 2025-10-28 | 61 |
| K251361 | Tyber Medical Distal Radius Plating System | HRS | 2025-07-30 | 90 |
| K242486 | Tyber Medical Anatomical Plating System | HRS | 2025-03-19 | 210 |
| K241218 | Tyber Medical Anatomical Plating System | HRS | 2024-05-31 | 30 |
| K233423 | Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System | HRS | 2023-12-21 | 72 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tyber Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tyber Medical, LLC?
FDA lists 31 510(k) clearances under the applicant name “Tyber Medical, LLC” (first 2013, latest 2026), across 8 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 Tyber Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tyber Medical, LLC is 90 days. Since 2017: 90 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tyber Medical, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 11); HWC (Screw, Fixation, Bone, 9); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4).
Next steps
- See all 31 Tyber Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Tyber Medical, 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.