Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
FDA 510(k) clearance K252085 · decided 2025-09-30
Clearance details
- K-number
- K252085
- Device name
- Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
- Applicant
- Wright Medical Technology, Inc. (Stryker Corporation)
- Decision
- Substantially Equivalent
- Date received
- 2025-07-02
- Decision date
- 2025-09-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.