510(k) K252085
K252085 is an FDA 510(k) premarket notification submitted by Wright Medical Technology, Inc. (Stryker Corporation) for the device "Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)". The FDA issued a decision of Substantially Equivalent on September 30, 2025. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Wright Medical Technology, Inc. (Stryker Corporation) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2025
- Date Received
- July 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type