Theken Surgical,Llc: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Theken Surgical,Llc” (first 1998, latest 2005), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| JDK | Prosthesis, Hip, Cement Restrictor | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Theken Surgical,Llc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050058 | THEKEN REVEAL VBR SYSTEM | MQP | 2005-05-17 | 126 |
| K041592 | CORAL SPINAL SYSTEM | KWP | 2004-09-16 | 94 |
| K032064 | THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM | MQP | 2004-02-20 | 232 |
| K012462 | THEKEN LARGE CEMENT RESTRICTOR | JDK | 2001-10-29 | 89 |
| K012278 | THEKEN SMALL CEMENT RESTRICTOR | JDK | 2001-10-17 | 90 |
| K010466 | TETHER ACFS | KWQ | 2001-05-16 | 89 |
| K994382 | NONLINEAR TAPER LAG SCREW | HWC | 2000-03-10 | 73 |
| K994383 | DOGBONE ACFS | KWQ | 2000-02-04 | 38 |
| K983622 | BODYFORM THORACO-LUMBAR FIXATION SYSTEM | KWQ | 1998-12-30 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Theken Surgical,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.
- Theken Spine, LLC (23 510(k)s)
- Theken Companies, LLC (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Theken Surgical,Llc?
FDA lists 9 510(k) clearances under the applicant name “Theken Surgical,Llc” (first 1998, latest 2005), 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 Theken Surgical,Llc?
The median time from FDA receipt to decision across 510(k)s cleared under the name Theken Surgical,Llc is 89 days.
Which FDA product codes appear under Theken Surgical,Llc?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3); JDK (Prosthesis, Hip, Cement Restrictor, 2); MQP (Spinal Vertebral Body Replacement Device, 2).
Next steps
- See all 9 Theken Surgical,Llc clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Theken Surgical,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.