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SeaSpine Skipjack System

by SeaSpine Orthopedics Corporation

510(k) K193418

SeaSpine Skipjack System is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K193418 on 13 Mar 2020, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193418 Date13 Mar 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K193418

19 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K193418
UDI-DISize and differences
Explorer TO ET1-102612
SeaSpine Orthopedics Corporation
ET1-102612 / ET1-10261210889981206468
Single use: yes
On the market
Explorer TO ET1-103012
SeaSpine Orthopedics Corporation
ET1-103012 / ET1-10301210889981184896
Single use: yes
On the market
Explorer TO ET1-142608
SeaSpine Orthopedics Corporation
ET1-142608 / ET1-14260810889981184902
Single use: yes
On the market
Explorer TO ET1-143008
SeaSpine Orthopedics Corporation
ET1-143008 / ET1-14300810889981184919
Single use: yes
On the market
Explorer TO ET1-172610
SeaSpine Orthopedics Corporation
ET1-172610 / ET1-17261010889981206475
Single use: yes
On the market
Explorer TO ET1-173010
SeaSpine Orthopedics Corporation
ET1-173010 / ET1-17301010889981206482
Single use: yes
On the market
Explorer TO ET1-302807
SeaSpine Orthopedics Corporation
ET1-302807 / ET1-30280710889981206499
Single use: yes
On the market
Explorer TO ET1-302808
SeaSpine Orthopedics Corporation
ET1-302808 / ET1-30280810889981206505
Single use: yes
On the market
Explorer TO ET1-302810
SeaSpine Orthopedics Corporation
ET1-302810 / ET1-30281010889981206529
Single use: yes
On the market
Explorer TO ET1-302812
SeaSpine Orthopedics Corporation
ET1-302812 / ET1-30281210889981206543
Single use: yes
On the market
Explorer TO ET1-303207
SeaSpine Orthopedics Corporation
ET1-303207 / ET1-30320710889981206550
Single use: yes
On the market
Explorer TO ET1-303208
SeaSpine Orthopedics Corporation
ET1-303208 / ET1-30320810889981206567
Single use: yes
On the market
Explorer TO ET1-303210
SeaSpine Orthopedics Corporation
ET1-303210 / ET1-30321010889981206581
Single use: yes
On the market
Explorer TO ET1-303212
SeaSpine Orthopedics Corporation
ET1-303212 / ET1-30321210889981206604
Single use: yes
On the market
Explorer TO ET1-382810
SeaSpine Orthopedics Corporation
ET1-382810 / ET1-38281010889981206727
Single use: yes
On the market
Explorer TO ET1-382812
SeaSpine Orthopedics Corporation
ET1-382812 / ET1-38281210889981206741
Single use: yes
On the market
Explorer TO ET1-383210
SeaSpine Orthopedics Corporation
ET1-383210 / ET1-38321010889981206758
Single use: yes
On the market
Explorer TO ET1-383212
SeaSpine Orthopedics Corporation
ET1-383212 / ET1-38321210889981206772
Single use: yes
On the market
Explorer TO ET2-001000
SeaSpine Orthopedics Corporation
ET2-001000 / ET2-00100010889981207137
Single use: no
On the market

Similar devices

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

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