Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
FDA 510(k) K253447 · Orthocon, Inc.
510(k) numberK253447
Submission
- Device name
- Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- Applicant
- Orthocon, Inc.
Stamford, CT, US - Received
- October 2, 2025
- Decision date
- March 16, 2026
- 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 |
|---|---|---|---|
| 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 |
| K141368 | Neuropace Burr Hole CoverGXR · Special | NeuroPace, Inc. | 07/11/2014SE |
More from NeuroPace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)MTJ · Special | 09/03/2026SE |
| K261265 | Permatage XT Settable Bone PuttyGXP · Special | 06/15/2026SE |
| K261439 | Permatage Flowable, Settable Hemostatic Bone PasteMTJ · Traditional | 06/03/2026SE |
| K253732 | Permatage Flowable, Settable Bone PasteGXP · Traditional | 03/13/2026SE |
| K253854 | MONTAGE XT Cranial CementGXP · Special | 01/02/2026SE |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty…MQV · Special | 12/05/2024SE |
| K243506 | Montage-XT Settable Bone PuttyMQV · Special | 11/18/2024SE |
| K241027 | Permatage Settable Bone PuttyGXP · Traditional | 09/26/2024SE |
| K233566 | Montage-XT Settable, Resorbable Bone PuttyMQV · Traditional | 08/21/2024SE |
| K242050 | Montage Settable Bone PuttyMQV · Special | 07/29/2024SE |
Questions and answers
When was Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) cleared by the FDA?
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (K253447) received a 510(k) decision of Substantially Equivalent on March 16, 2026, 165 days after the submission was received.
What is the product code of K253447?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.