Product code MTJ
- Device name
- Wax, Bone
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023-10-12 |
| K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023-08-30 |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | Orthocon, Inc. | 2023-07-11 |
| K200452 | Meril-Bonewax | M/s. Meril Endo Surgery Private Limited. | 2023-03-27 |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2022-03-11 |
| K202363 | HBP7 Settable Hemostatic Bone Putty | Orthocon, Inc. | 2021-01-19 |
| K193052 | HBP6 Settable, Resorbable Hemostatic Bone Paste | Orthocon, Inc. | 2020-03-27 |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | Orthocon, Inc. | 2019-07-18 |
| K153317 | HEMASORBPLUS Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2016-11-30 |
| K153095 | ROP Resorbable Hemostasis Material | Resorbable Orthopedic Products, LLC | 2016-02-17 |
| K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2015-10-15 |
| K142348 | OsteoSeal Bone Hemostat | Hemostasis, LLC | 2015-01-23 |
| K143069 | HEMASORBPLUS press Resorable Hemostatic Bone Putty | Orthocon, Inc. | 2014-12-22 |
| K141502 | HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2014-10-03 |
| K142339 | HEMASORB Resorbable Hemostatic Bone Putty | Orthocon, LLC | 2014-09-26 |
| K140117 | AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2014-02-11 |
| K123243 | HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2013-04-05 |
| K122156 | ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2013-01-28 |
| K121953 | HEMASORB APPLY | Orthocon, Inc. | 2012-11-21 |
| K111575 | HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX | Orthocon, Inc. | 2012-05-23 |
| K113627 | HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY | Orthocon | 2012-02-17 |
| K113079 | SYNTHES HEMOSTATIC BONE PUTTY | Synthes (Usa) Products, LLC/Norian Corporation | 2011-12-13 |
| K111538 | SKAFFOLD CIS | Skeletal Kinetics, LLC | 2011-10-25 |
| K111524 | MP 719 | Marine Polymer Technologies, Inc. | 2011-07-22 |
| K103822 | SYNTHES HEMOSTATIC BONE PUTTY (HBP) | Synthes USA Products, LLC | 2011-05-19 |
| K102762 | ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR | Orthocon, Inc. | 2011-02-15 |
| K102071 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | Ceremed , Inc. | 2010-10-08 |
| K091636 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | Ceremed , Inc. | 2009-06-22 |
| K091121 | ORTHOSTAT | Orthocon, Inc. | 2009-04-28 |
| K082491 | OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE | Ceremed , Inc. | 2008-09-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08906070900214 | MERIL - BONEWAX™ | MERIL ENDO SURGERY PRIVATE LIMITED | 2026-03-28 |
| 08904255228641 | MERIL - BONEWAX™ | MERIL ENDO SURGERY PRIVATE LIMITED | 2026-03-28 |
| 00850391007436 | Montage CT 7cc | ABYRX, INC. | 2025-04-07 |
| 30884389024212 | MEDLINE INDUSTRIES | MEDLINE INDUSTRIES, INC. | 2024-04-24 |
| 10884389024218 | MEDLINE INDUSTRIES | MEDLINE INDUSTRIES, INC. | 2024-04-24 |
| 00850391007238 | Permatage 5cc | ABYRX, INC. | 2023-10-24 |
| 00850391007337 | UNM Montage Flowable Tips (3x) | ABYRX, INC. | 2022-08-25 |
| 10080196024216 | MEDLINE INDUSTRIES | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 14026704635655 | DEKNATEL | TELEFLEX INCORPORATED | 2019-05-14 |
| 00858439001552 | BoneSeal 2x2.5 gram Ingot | HEMOSTASIS, LLC | 2019-05-06 |
| 00858439001538 | BoneSeal 2.5 gram Ingot | HEMOSTASIS, LLC | 2019-05-06 |
| 00850391007177 | Montage 2cc Multipack | ABYRX, INC. | 2017-04-19 |
| 00850391007139 | Hemasorb 1.0 gram with Spatula | ABYRX, INC. | 2017-02-07 |
| 00850391007061 | Hemasorb Press 4.0 gram | ABYRX, INC. | 2017-01-25 |
| 00850391007023 | Hemasorb 2.0 gram with Spatula | ABYRX, INC. | 2017-01-24 |
| 00850391007078 | AHBP 2.5 gram | ABYRX, INC. | 2016-12-14 |
| 00848782005604 | Genzyme Bone Wax | Surgical Specialties México, S. de R.L. de C.V. | 2015-10-22 |
| 00848782005611 | MEDLINE BONEWAX YELLOW | Surgical Specialties México, S. de R.L. de C.V. | 2015-10-22 |
| 00848782005628 | MEDLINE BONE WAX WHITE | Surgical Specialties México, S. de R.L. de C.V. | 2015-10-22 |
| 00848782008261 | Bone Wax White | Surgical Specialties México, S. de R.L. de C.V. | 2015-10-20 |
| 00848782008247 | Ssc Bone Wax | Surgical Specialties México, S. de R.L. de C.V. | 2015-10-20 |
| 00848782008254 | Bone Wax White | Surgical Specialties México, S. de R.L. de C.V. | 2015-10-20 |
| 04026704590476 | DEKNATEL | TELEFLEX INCORPORATED | 2015-10-16 |
| 05413760467450 | Ostene | Apatech Ltd | 2015-09-24 |
| 05413760467467 | Ostene | Apatech Ltd | 2015-09-24 |
| 05413760467474 | Ostene | Apatech Ltd | 2015-09-24 |
| 10705031056992 | ETHICON | ETHICON, LLC | 2015-09-23 |
| 10705031036826 | ETHICON | Ethicon Inc. | 2015-09-01 |
| 10884521196261 | Bone Wax | Covidien LP | 2015-08-31 |
| 20884521196268 | Bone Wax | Covidien LP | 2015-08-31 |