FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cove Strip
K Number: K230486
·
Decision Aug 21, 2023
Classifications
1
FEI Numbers
234
Registration Numbers
234
Same Product Code
483
Applicant Total
62
Review Days
179
Basic Information
- Device Name
- Cove Strip
- K Number
- K230486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SeaSpine Orthopedics Corporation
- Date Received
- February 23, 2023
- Decision Date
- August 21, 2023
- Product Code
- MQV
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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Other Clearances by SeaSpine Orthopedics Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K250908 | Virata Spinal Fixation System | Jun 18, 2025 | Substantially Equivalent |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | Apr 2, 2025 | Substantially Equivalent |
| K242273 | Cove Putty, OsteoCove Putty | Sep 25, 2024 | Substantially Equivalent |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | Jun 20, 2024 | Substantially Equivalent |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | Apr 26, 2024 | Substantially Equivalent |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System | Apr 19, 2024 | Substantially Equivalent |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | Jan 12, 2024 | Substantially Equivalent |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | Nov 28, 2023 | Substantially Equivalent |
| K232668 | Cove Strip, OsteoCove Strip | Sep 27, 2023 | Substantially Equivalent |
| K231030 | Cove Putty, OsteoCove Putty | Sep 14, 2023 | Substantially Equivalent |