Meril-Bonewax
FDA 510(k) K200452 · M/s. Meril Endo Surgery Private Limited.
510(k) numberK200452
Submission
- Device name
- Meril-Bonewax
- Applicant
- M/s. Meril Endo Surgery Private Limited.
Chala, Vapi, IN - Received
- February 24, 2020
- Decision date
- March 27, 2023
- 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 |
| 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 |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic BoneMTJ · Traditional | Orthocon, Inc. | 07/18/2019SE |
| K153317 | HEMASORBPLUS Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 11/30/2016SE |
More from Orthocon, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special | 09/23/2025SE |
| K233386 | Monik - Disposable Endoscopic TrocarGCJ · Traditional | 05/24/2024SE |
| K232246 | 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…NEW · Traditional | 04/25/2024SE |
| K230981 | Meriglu Topical Skin AdhesiveMPN · Traditional | 03/16/2024SE |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…GDW · Traditional | 02/05/2021SE |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip ApplierFZP · Traditional | 11/23/2020SE |
| K172146 | MeristeelGAQ · Traditional | 02/01/2018SE |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Special | 10/20/2017SE |
| K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable…GAM · Special | 09/28/2017SE |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Traditional | 05/31/2016SE |
Questions and answers
When was Meril-Bonewax cleared by the FDA?
Meril-Bonewax (K200452) received a 510(k) decision of Substantially Equivalent on March 27, 2023, 1,127 days after the submission was received.
What is the product code of K200452?
The FDA product code is MTJ – Wax, Bone, a Unclassified device.