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SeaSpine WaveForm™ A Interbody System

by SeaSpine Orthopedics Corporation

510(k) K210583

SeaSpine WaveForm™ A Interbody System is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K210583 on 2 Jun 2021, active as of 25 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 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210583 Date2 Jun 2021ClearedStatusActive

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  • Withdrawn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 K210583

1 device · 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 K210583
UDI-DISize and differences
WaveForm TA WA1-301010
SeaSpine Orthopedics Corporation
WA1-301010 / WA1-30101010889981263676 —On the market

Similar devices

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

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