Intelligent Implant Systems, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Intelligent Implant Systems, LLC” (first 2012, latest 2018), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 104 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 | 1 | 119 |
| 2013 | 1 | 39 |
| 2014 | 0 | — |
| 2015 | 1 | 96 |
| 2016 | 1 | 84 |
| 2017 | 1 | 115 |
| 2018 | 1 | 111 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 Intelligent Implant Systems, LLC took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 81 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Intelligent Implant Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173935 | Mediant Anterior Cervical Plating System | KWQ | 2018-04-16 | 111 |
| K163056 | Revolution Spinal Fixation System | NKB | 2017-02-24 | 115 |
| K160216 | Revolution Spinal Fixation System | NKB | 2016-04-22 | 84 |
| K142939 | Revolution Spinal Fixation System | NKB | 2015-01-13 | 96 |
| K132900 | MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM | KWP | 2013-10-25 | 39 |
| K121682 | ACTIVE SCREW BONE SCREW | HWC | 2012-10-04 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Intelligent Implant Systems, 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.
- Intelligent Hearing Systems (13 510(k)s)
- Intelligent Medical Devices, Inc. (4 510(k)s)
- Intelligent Medicine, Inc. (4 510(k)s)
- Intelligent Orthopaedics, Ltd. (3 510(k)s)
- Intelligent Images Srl (2 510(k)s)
- Intelligent Medical Systems (2 510(k)s)
- Intelligent Product Limited Co. (2 510(k)s)
- Intelligent Surgical Lasers, Inc. (2 510(k)s)
- Intelligent Ultrasound Limited (1 510(k)s)
- Intelligent Dots, LLC (1 510(k)s)
- Intelligent Endoscopy (1 510(k)s)
- Intelligent Instruments Pvt. , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intelligent Implant Systems, LLC?
FDA lists 6 510(k) clearances under the applicant name “Intelligent Implant Systems, LLC” (first 2012, latest 2018), across 4 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 Intelligent Implant Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intelligent Implant Systems, LLC is 104 days.
Which FDA product codes appear under Intelligent Implant Systems, LLC?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 3); HWC (Screw, Fixation, Bone, 1); KWP (Appliance, Fixation, Spinal Interlaminal, 1).
Next steps
- See all 6 Intelligent Implant Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code NKB, Intelligent Implant Systems, 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.