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SeptAlign FG-0038

by Spirair

SeptAlign FG-0038 (SPLN001) is a Class II device made by Spirair, cleared under FDA 510(k) K260620 on 30 Jul 2026 and listed in FDA GUDID since 3 Aug 2026 (UDI-DI 00860011696346), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K260620

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860011696346 UDI-DI Date3 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK260620 Date30 Jul 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K260620 decided 30 Jul 2026 Active
  • FDA GUDID UDI-DI 00860011696346 listed 3 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K260620
  2. Listed FDA GUDID 00860011696346

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SeptAlign
Generic name
Nasal cartilage support implant, bioabsorbable
Model / Ref / Catalog
FG-0038, SPLN001
Primary DI / UDI-DI
00860011696346
510(k) Number
FDA product code
NHB
GMDN term
Nasal cartilage support implant, bioabsorbable
Device class
Class II
Regulation number
874.3620
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable).

Other devices from Spirair

See all devices from Spirair →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)