MONTAGE-QS Settable, Resorbable Hemostatic Bone
FDA 510(k) K191140 · Orthocon, Inc.
510(k) numberK191140
Submission
- Device name
- MONTAGE-QS Settable, Resorbable Hemostatic Bone
- Applicant
- Orthocon, Inc.
Irvington, NY, US - Received
- April 30, 2019
- Decision date
- July 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MTJ – Wax, Bone
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code MTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)MTJ · Special | Orthocon, Inc. | 09/03/2026SE |
| K261439 | Permatage Flowable, Settable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 06/03/2026SE |
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Special | Orthocon, Inc. | 10/12/2023SE |
| K213418 | MONTAGE Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 08/30/2023SE |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 07/11/2023SE |
| K200452 | Meril-BonewaxMTJ · Traditional | M/s. Meril Endo Surgery Private Limited. | 03/27/2023SE |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 03/11/2022SE |
| K202363 | HBP7 Settable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 01/19/2021SE |
| K193052 | HBP6 Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 03/27/2020SE |
| K153317 | HEMASORBPLUS Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 11/30/2016SE |
More from Orthocon, 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 |
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)GXR · Traditional | 03/16/2026SE |
| 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 |
Questions and answers
When was MONTAGE-QS Settable, Resorbable Hemostatic Bone cleared by the FDA?
MONTAGE-QS Settable, Resorbable Hemostatic Bone (K191140) received a 510(k) decision of Substantially Equivalent on July 18, 2019, 79 days after the submission was received.
What is the product code of K191140?
The FDA product code is MTJ – Wax, Bone, a Unclassified device.