Theken Spine, LLC: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Theken Spine, LLC” (first 2007, latest 2012), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 | 4 | 70 |
| 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 6 | 6 |
| MQP | Spinal Vertebral Body Replacement Device | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (23)
Most recent Theken Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121482 | INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY | HRX | 2012-08-28 | 102 |
| K121211 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | OVD | 2012-06-27 | 68 |
| K120829 | STAINLESS STEEL SPINAL SYSTEM | NKB | 2012-05-30 | 72 |
| K120047 | CORAL SPINAL SYSTEM | NKB | 2012-02-03 | 28 |
| K111675 | VU C*POD INTERVERTEBRAL BODY FUSION DEVICE | ODP | 2011-08-02 | 48 |
| K103228 | PARAMOUNT R IBF DEVICE | MAX | 2011-01-05 | 64 |
| K102323 | CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE | OVE | 2010-12-16 | 121 |
| K101310 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | OVD | 2010-09-02 | 114 |
| K100970 | STAINLESS STEEL SPINAL SYSTEM | NKB | 2010-08-12 | 126 |
| K091266 | THEKEN CORAL SPINAL SYSTEM | NKB | 2009-06-10 | 41 |
13 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2010-08-26.
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.
- Theken Surgical,Llc (6 510(k)s)
- Theken Companies, LLC (4 510(k)s)
- Theken Surgical (3 510(k)s)
- Theken Companies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Theken Spine, LLC?
FDA lists 23 510(k) clearances under the applicant name “Theken Spine, LLC” (first 2007, latest 2012), across 10 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 Theken Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Theken Spine, LLC is 88 days.
Which FDA product codes appear under Theken Spine, LLC?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 6); MQP (Spinal Vertebral Body Replacement Device, 3); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 3).
Next steps
- See all 23 Theken Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code NKB, Theken 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 (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.