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510(k) K230486

Cove Strip by SeaSpine Orthopedics Corporation — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2023
Date Received
February 23, 2023
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

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  • K233694 — Meridian Interbody System; WaveForm A Interbody System (January 12, 2024)
  • K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody System (November 28, 2023)
  • K232668 — Cove Strip, OsteoCove Strip (September 27, 2023)
  • K231030 — Cove Putty, OsteoCove Putty (September 14, 2023)

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