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"
25–48 of 69
Search insights Median review: 87d Cleared: 100% Top manufacturer: SeaSpine Orthopedics Corporation Lead specialty: Orthopedic
Cleared Sep 01, 2021
Admiral ACP System
K212139 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared Aug 30, 2021
Shoreline Threaded TruProfile® Plate
K211903 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 70d
Cleared Jul 07, 2021
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo,...
K210497 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 135d
Cleared Jun 23, 2021
Mariner Deformity System
K211606 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 29d
Cleared Jun 02, 2021
SeaSpine WaveForm™ A Interbody System
K210583 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 96d
Cleared Dec 15, 2020
WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA...
K201755 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 169d
Cleared Nov 25, 2020
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo,...
K201193 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 205d
Cleared Sep 18, 2020
Seaspine WaveForm C Interbody System
K201073 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 149d
Cleared Sep 14, 2020
Shoreline ACS (Anterior Cervical System)
K201646 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 89d
Cleared Aug 26, 2020
Admiral ACP System
K202064 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 30d
Cleared Aug 05, 2020
Mariner Cap System
K201240 · OWI
SeaSpine Orthopedics Corporation
Orthopedic · 89d
Cleared Jun 10, 2020
SeaSpine Meridian System, SeaSpine Regatta Lateral System
K200879 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 69d
Cleared May 28, 2020
Meridian Anterior Plate System, Regatta Lateral Plate System
K200885 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 56d
Cleared May 11, 2020
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
K200290 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 96d
Cleared Apr 24, 2020
SeaSpine Reef TH System
K193636 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 119d
Cleared Mar 25, 2020
NorthStar™ OCT Spinal System
K193615 · NKG
SeaSpine Orthopedics Corporation
Orthopedic · 90d
Cleared Mar 13, 2020
SeaSpine Skipjack System
K193418 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 95d
Cleared Feb 28, 2020
Daytona® Small Stature Spinal System
K200381 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 10d
Cleared Feb 13, 2020
Daytona® Small Stature Growth Rod Conversion Set
K193224 · PGM
SeaSpine Orthopedics Corporation
Orthopedic · 83d
Cleared Dec 03, 2019
SeaSpine Beachside System
K192132 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 118d
Cleared Nov 30, 2019
Resorbable Mesh Device
K193040 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 30d
Cleared Jul 19, 2019
Mariner MIS Pedicle Screw System
K191648 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 29d
Cleared May 23, 2019
Mariner Outrigger Revision System
K183639 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 148d
Cleared Apr 29, 2019
SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
K190655 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 46d