I.T.S. Implantat-Technologie-Systeme GmbH: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “I.T.S. Implantat-Technologie-Systeme GmbH” (first 2004, latest 2010), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 10 | 10 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDS | Nail, Fixation, Bone | 1 | 1 |
| NDF | Plate, Fixation, Bone, Non-Spinal, Metallic | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent I.T.S. Implantat-Technologie-Systeme GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093868 | I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM | HRS | 2010-08-05 | 231 |
| K080706 | CONNEXX LOCKING TIBIA NAIL | JDS | 2008-06-09 | 89 |
| K080184 | DISTAL HUMERAL PLATES WITH ANGULAR STABILITY | HRS | 2008-03-26 | 61 |
| K063672 | FIBULA PLATE PROLOCK WITH ANGULAR STABILITY | HRS | 2007-02-02 | 53 |
| K063166 | I.T.S. PELVIC RECONSTRUCTION SYSTEM | HRS | 2006-12-22 | 65 |
| K060156 | STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM | HRS | 2006-03-20 | 59 |
| K052368 | OLECRANONPLATE WITH ANGULAR STABILITY | HRS | 2005-10-17 | 49 |
| K051642 | FR.O.H. CALCANEUS REPAIR SYSTEM | NDF | 2005-08-22 | 63 |
| K052011 | PILONPLATE WITH ANGULAR STABILITY | HRS | 2005-08-10 | 16 |
| K051412 | HUMERAL HEAD PLATE WITH ANGULAR STABILITY | HRS | 2005-07-11 | 41 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named I.T.S. Implantat-Technologie-Systeme GmbH.
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 I.T.S. Implantat-Technologie-Systeme GmbH?
FDA lists 13 510(k) clearances under the applicant name “I.T.S. Implantat-Technologie-Systeme GmbH” (first 2004, latest 2010), 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 I.T.S. Implantat-Technologie-Systeme GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name I.T.S. Implantat-Technologie-Systeme GmbH is 63 days.
Which FDA product codes appear under I.T.S. Implantat-Technologie-Systeme GmbH?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 10); HWC (Screw, Fixation, Bone, 1); JDS (Nail, Fixation, Bone, 1).
Next steps
- See all 13 I.T.S. Implantat-Technologie-Systeme GmbH clearances with predicates and recalls
- Run predicate analysis for product code HRS, I.T.S. Implantat-Technologie-Systeme GmbH'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.