# K232668: Cove Strip, OsteoCove Strip

- Pathway: 510(k) (Special)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Sep 27, 2023 after 26 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K960978 (1996). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230486: Cove Strip, SeaSpine Orthopedics Corporation (2023) Summary page 6.

## Indications for use
Cove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cove Strip resorbs and is replaced with bone during the healing process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. OsteoCove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. OsteoCove Strip resorbs and is replaced with bone during the healing process. OsteoCove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

Source page: https://510kreport.com/device/K232668
Methodology: https://510kreport.com/methodology