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510(k) K232668

Cove Strip, OsteoCove Strip by SeaSpine Orthopedics Corporation — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
September 1, 2023
Clearance Type
Special
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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  • K242273 — Cove Putty, OsteoCove Putty (September 25, 2024)
  • K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral S (June 20, 2024)
  • K240566 — Reef L Interbody System; WaveForm L Interbody System (April 26, 2024)
  • K232566 — NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System (April 19, 2024)
  • K233694 — Meridian Interbody System; WaveForm A Interbody System (January 12, 2024)
  • K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody System (November 28, 2023)
  • K231030 — Cove Putty, OsteoCove Putty (September 14, 2023)
  • K230486 — Cove Strip (August 21, 2023)

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