Cove Putty, OsteoCove Putty— 510(k) K242273
Substantially EquivalentSeaSpine Orthopedics Corporation
FDA 510(k) clearance K242273 for Cove Putty, OsteoCove Putty, Substantially Equivalent on 2024-09-25. Applicant: SeaSpine Orthopedics Corporation. Device class: 2.
Clearance details
- Applicant
- SeaSpine Orthopedics Corporation
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code MQV
view allMore clearances from SeaSpine Orthopedics Corporation
view allAdverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K242273
K-number listed on FDA's recall record- Z-0919-2025 — OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
- Z-0955-2025 — OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K242273.
Data sourced from openFDA. This site is unofficial and independent of the FDA.