Cranial Loop Cranial Bone Fixation System
FDA 510(k) K101235 · Neos Surgery S.L
510(k) numberK101235
Submission
- Device name
- Cranial Loop Cranial Bone Fixation System
- Applicant
- Neos Surgery S.L
Alexandria, VA, US - Received
- May 3, 2010
- Decision date
- October 25, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)GXR · Traditional | Orthocon, Inc. | 03/16/2026SE |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special | Neos Surgery S.L | 02/16/2024SE |
| K221606 | Absorbable Cranial Flap Fixation SystemGXR · Traditional | Chendu Medart Medical Scientific Co., Ltd. | 11/21/2023SE |
| K192310 | Flap Fixator, Burr Hole CoverGXR · Traditional | Ossaware Biotech Co., Ltd. | 06/03/2020SE |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateGXR · Traditional | Neurovention, LLC | 03/13/2020SE |
| K181539 | OSSDSIGN CranioplugGXR · Traditional | Ossdsign AB | 10/12/2018SE |
| K181382 | GuardianTM Burr Hole Cover SystemGXR · Abbreviated | St Jude Medical | 07/20/2018SE |
| K160739 | Cranial COVERGXR · Traditional | Neos Surgery S.L | 06/12/2016SE |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR · Traditional | St Jude Medical | 06/09/2016SE |
| K140309 | CranioplugGXR · Traditional | Ossdsign AB | 10/03/2014SE |
More from Ossdsign AB
| 510(k) | Device | Decision |
|---|---|---|
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special | 02/16/2024SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | 10/19/2022SE |
| K211613 | Stern Fix Sternal Stabilization SystemJDQ · Traditional | 01/19/2022SE |
| K160739 | Cranial COVERGXR · Traditional | 06/12/2016SE |
| K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemGXR · Traditional | 09/30/2013SE |
Questions and answers
When was Cranial Loop Cranial Bone Fixation System cleared by the FDA?
Cranial Loop Cranial Bone Fixation System (K101235) received a 510(k) decision of Substantially Equivalent on October 25, 2010, 175 days after the submission was received.
What is the product code of K101235?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.