NOX · Filler, Bone Void, Synthetic Peptide
· Class 3
Overview
| Product Code | NOX |
|---|---|
| Device Name | Filler, Bone Void, Synthetic Peptide |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240001 | PearlMatrix Bone Graft | Cerapedics, Inc. | Jun 18, 2025 | APPR |
| P140019 | I-FACTOR PEPTIDE ENHANCED BONE GRAFT | Cerapedics, LLC | Nov 3, 2015 | APPR |
| P100006 | AUGMENT BONE GRAFT | Biomimetic Therapeutics, LLC | Sep 1, 2015 | APPR |
Top Applicants
- Biomimetic Therapeutics, LLC — 1 clearance
- Cerapedics, Inc. — 1 clearance
- Cerapedics, LLC — 1 clearance
