Data / Medical devices / Germany / SK Pharma Logistics GMBH
SK Pharma Logistics GMBH: FDA-registered device maker in Bielefeld North Rhine-Westphalia, Germany, 8 510(k) clearances
SK Pharma Logistics GMBH is registered with the FDA (registration 3017155536) in Bielefeld North Rhine-Westphalia, Germany. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017155536
- Address
- Remusweg 8, Bielefeld North Rhine-Westphalia, Germany, 33729
- Owner or operator
- SK Pharma Logistics GmbH (10091163)
- Roles
- Exporter to the US
- First device listed
- July 15, 2024
- Registered through
- 2026
- Brand names listed
- Cage Bent Curette Kit, Cage Instrument Kit, Cage Pusher Kit, Cage holder, Cage puller, Cage straight curette kit, Cement Pusher, Compressor Distractor Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bender | HXW | 1 | Exporter to the US | accessdata.fda.gov |
| Bone Cement | LOD | 2 | Exporter to the US | accessdata.fda.gov |
| Bone Cement, Posterior Screw Augmentation | PML | 2 | Exporter to the US | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Exporter to the US | accessdata.fda.gov |
| Dispenser, Cement | KIH | 1 | Exporter to the US | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Exporter to the US | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Exporter to the US | accessdata.fda.gov |
| Probe | HXB | 1 | Exporter to the US | accessdata.fda.gov |
| Retractor | GAD | 1 | Exporter to the US | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Exporter to the US | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Exporter to the US | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Exporter to the US | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2024 | K243693 | NEO Pedicle Screw System | NKB | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| August 26, 2022 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | PML | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| October 28, 2021 | K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | PML | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| May 18, 2021 | K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | LOD | Substantially Equivalent | Osartis GmbH | accessdata.fda.gov |
| December 13, 2019 | K191796 | Neo Cage System | MAX | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| January 29, 2019 | K181048 | Neo Cage System TM | MAX | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| September 12, 2017 | K171582 | NEO Pedicle Screw System | NKB | Substantially Equivalent | Neo Medical SA | accessdata.fda.gov |
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Retractor
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Bone Cement, Posterior Screw Augmentation
- All makers of Bone Cement
Updated December 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.