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SU-POR Surgical Implant 4768

by Poriferous, LLC

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) K140437

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815285025088 UDI-DI Date13 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK140437 Date13 Jun 2014IssuedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SU-POR Surgical Implant
Generic name
Polyethylene craniofacial tissue reconstructive material
Model / Ref / Catalog
4768
Primary DI / UDI-DI
00815285025088
510(k) Number
FDA product code
KKY
GMDN term
Polyethylene craniofacial tissue reconstructive material
Device class
Class II
Regulation number
878.3500
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K140437)

Other devices from Poriferous, LLC

See all devices from Poriferous, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No