ROP Resorbable Hemostasis Material
FDA 510(k) clearance K153095 · decided 2016-02-17
Clearance details
- K-number
- K153095
- Device name
- ROP Resorbable Hemostasis Material
- Applicant
- Resorbable Orthopedic Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-10-26
- Decision date
- 2016-02-17
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- MTJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Addison, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Permatage Flowable, Settable Hemostatic Bone Paste (K261439) | Orthocon, Inc. | 2026-06-03 |
| Montage- XT Settable, Resorbable Hemostatic Bone Putty (K232998) | Orthocon, Inc. | 2023-10-12 |
| MONTAGE Settable, Resorbable Hemostatic Bone Putty (K213418) | Orthocon, Inc. | 2023-08-30 |
| Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (K231386) | Orthocon, Inc. | 2023-07-11 |
| Meril-Bonewax (K200452) | M/s. Meril Endo Surgery Private Limited. | 2023-03-27 |
| MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (K220315) | Orthocon, Inc. | 2022-03-11 |
| HBP7 Settable Hemostatic Bone Putty (K202363) | Orthocon, Inc. | 2021-01-19 |
| HBP6 Settable, Resorbable Hemostatic Bone Paste (K193052) | Orthocon, Inc. | 2020-03-27 |
| MONTAGE-QS Settable, Resorbable Hemostatic Bone (K191140) | Orthocon, Inc. | 2019-07-18 |
| HEMASORBPLUS Resorbable Hemostatic Bone Putty (K153317) | Orthocon, Inc. | 2016-11-30 |
| MONTAGE Settable, Resorbable Hemostatic Bone Putty (K152005) | Orthocon, Inc. | 2015-10-15 |
| OsteoSeal Bone Hemostat (K142348) | Hemostasis, LLC | 2015-01-23 |
Recalls involving this device
No recalls on record reference this clearance.