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SUPRAFOIL Code F-SS-04

by S. Jackson, Inc.

SUPRAFOIL Code F-SS-04 is a Class II device made by S. Jackson, Inc., cleared under FDA 510(k) K973379 on 25 Sep 1997 and listed in FDA GUDID since 19 Jul 2017 (UDI-DI 00816848023749), 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) K973379

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 Number00816848023749 UDI-DI Date19 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973379 Date25 Sep 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973379 decided 25 Sep 1997 Active
  • FDA GUDID UDI-DI 00816848023749 listed 19 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973379
  2. Listed FDA GUDID 00816848023749

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Suprafoil
Generic name
Orbital wall/rim prosthesis
Model / Ref / Catalog
Code F-SS-04
Primary DI / UDI-DI
00816848023749
510(k) Number
FDA product code
FTM
GMDN term
Orbital wall/rim prosthesis
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orbital rim prosthesis

Cleared under the same submission (K973379)

Similar devices

Other devices filed under FDA product code FTM (Mesh, Surgical).

Other devices from S. Jackson, Inc.

See all devices from S. Jackson, Inc. →

Properties

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