COLLAGRAFT STRIP BONE GRAFT MATRIX - 3X
510(k) K000122
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000122 | Date20 Sep 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQV
- Models / Variants
- 3X
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Collagraft Strip Bone Graft Matrix is a bone graft substitute classified as a bone graft substitute (allograft) under the FDA’s nomenclature. It is designed to fill bone defects by providing a scaffold to support new bone formation, aiding in the repair of bony structures during orthopedic procedures. Constructed from processed bovine-derived collagen, it mimics the natural extracellular matrix to facilitate integration with host tissue. This device is intended for use as a bone filler in orthopedic applications where additional structural support is required.
The Collagraft Strip Bone Graft Matrix is supplied in sterile, single-use configurations (Models 1X, 3X, or 6X), each containing 1, 3, or 6 strips per box. It is intended for use in orthopedic settings and is regulated under the FDA’s 510(k) clearance as a substantially equivalent device to predecessors, reviewed by the Orthopedic Devices Panel (OR). The product adheres to traditional clearance pathways and is not intended for MRI use. Storage instructions and additional handling details are specified in the accompanying labeling.
Other devices from Neucoll, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of orthopedic procedures is the Collagraft Strip Bone Graft Matrix intended to support with its bone-filling function?
The Collagraft Strip Bone Graft Matrix is designed to fill bone defects and provide structural support during orthopedic procedures where new bone formation is needed. It acts as a scaffold to aid in the repair of bony structures, particularly in cases requiring additional support, such as bone grafting or defect bridging in surgeries like spinal fusion, joint replacements, or fracture repairs.
How is the Collagraft Strip Bone Graft Matrix packaged and what does each box contain?
The Collagraft Strip Bone Graft Matrix is supplied in sterile, single-use boxes, available in three configurations: Model 1X (1 strip per box), Model 3X (3 strips per box), and Model 6X (6 strips per box). Each box contains the specified number of strips ready for immediate use in orthopedic procedures.
Is the Collagraft Strip Bone Graft Matrix reusable, or is it intended for single-use only?
The Collagraft Strip Bone Graft Matrix is explicitly intended for single-use only. This ensures sterility and maintains the integrity of the bovine-derived collagen scaffold, which is designed to support new bone formation without risk of contamination from repeated use.
What material is the Collagraft Strip Bone Graft Matrix made from, and how does it function in the body?
The Collagraft Strip Bone Graft Matrix is constructed from processed bovine-derived collagen, which mimics the natural extracellular matrix. This material provides a scaffold that integrates with host tissue, promoting new bone formation and aiding in the repair of bony defects during orthopedic procedures.
Can the Collagraft Strip Bone Graft Matrix be used in MRI scans, or does it have any restrictions related to imaging?
The Collagraft Strip Bone Graft Matrix is explicitly not intended for MRI use, as noted in its labeling. This restriction is likely due to the collagen-based material, which may not be safe or compatible with magnetic resonance imaging environments.