Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

69 results for "SeaSpine Orthopedics Corporation"
1–24 of 69
Search insights Median review: 87d Cleared: 100% Top manufacturer: SeaSpine Orthopedics Corporation Lead specialty: Orthopedic
Cleared Oct 29, 2026
Virata Spinal Fixation System
K262731 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 90d
Cleared Oct 29, 2026
Convoy Expandable Corpectomy System
K262574 · MQP
SeaSpine Orthopedics Corporation
Orthopedic · 94d
Cleared Jul 01, 2026
Admiral ACP System
K253420 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 273d
Cleared Jun 18, 2025
Virata Spinal Fixation System
K250908 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 84d
Cleared Apr 02, 2025
FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
K243659 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 126d
Cleared Sep 25, 2024
Cove Putty, OsteoCove Putty
K242273 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared Jun 20, 2024
Shoreline ACS Interbody System
K241466 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 28d
Cleared Apr 26, 2024
Reef L Interbody System
K240566 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 57d
Cleared Apr 19, 2024
NewPort Spinal System
K232566 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 239d
Cleared Jan 12, 2024
Meridian Interbody System
K233694 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 56d
Cleared Nov 28, 2023
Shoreline ACS Interbody System
K233414 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 49d
Cleared Sep 27, 2023
Cove Strip, OsteoCove Strip
K232668 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 26d
Cleared Sep 14, 2023
Cove Putty, OsteoCove Putty
K231030 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 156d
Cleared Aug 21, 2023
Cove Strip
K230486 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 179d
Cleared Feb 03, 2023
Manta Ray TDF Spacer
K220296 · ODP
SeaSpine Orthopedics Corporation
Orthopedic · 366d
Cleared Dec 09, 2022
SeaSpine 7D Navigation Instruments
K222753 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 88d
Cleared Nov 07, 2022
WaveForm A Interbody System
K222732 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 59d
Cleared Sep 07, 2022
Mariner RDX System
K222110 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 51d
Cleared May 10, 2022
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
K220711 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 60d
Cleared May 04, 2022
WaveForm L System, WaveForm TO System, WaveForm TA System
K213420 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 196d
Cleared Dec 14, 2021
SeaSpine WaveForm C Interbody System
K212904 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 92d
Cleared Dec 09, 2021
SeaSpine WaveForm, C Interbody System
K213359 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 58d
Cleared Sep 21, 2021
Mariner Pedicle Screw System
K212692 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 27d
Cleared Sep 10, 2021
Explorer TO System
K212540 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 29d