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Pre-Formed Splint Blanks

by Fred Sammons, Inc.

510(k) K772416

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

We provide high-quality medical splints and orthotics for individuals with joint pain or musculoskeletal injuries. Our products are designed to provide stability, support, and comfort, while promoting healing and recovery.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK772416 Date5 Jan 1978ClearedStatusActive

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  • Withdrawn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

510(k)

510(k) Number
FDA Product Code
ILH
Device Class
Class I
Regulation
21 CFR Part 890.3475
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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