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SeaSpine Spacer System NM - and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD

by SeaSpine Orthopedics Corporation

510(k) K201193

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201193 Date25 Nov 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

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  • Withdrawn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
Models / Variants
and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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