Product code HSS— Orthopedic

MEDISHIELD CERVICAL COLLAR

Classification name: Halter, Head, Traction
Device class: Class 1
Regulation: 21 CFR 888.5890
Advisory panel: Orthopedic
Total cleared: 3
First cleared: 1976-11-01
Most recent: 1977-06-27

Market context for product code HSS

FDA has cleared 3 devices under product code HSS between 1976 and 1977, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19772 clearances
19761 clearance

Top applicants under product code HSS

Orthopedic Systems, Inc.1 clearance
Orthopedic Equipment Co., Inc.1 clearance
Fraser Sweatman, Inc.1 clearance

Recent clearances under product code HSS

K771109 — ORTHOPEDIC SOFT GOODSOrthopedic Systems, Inc.·1977-06-27
K770910 — MEDISHIELD CERVICAL COLLARFraser Sweatman, Inc.·1977-05-25
K760869 — SPLIT CERVICAL COLLAR/HEAD HALTEROrthopedic Equipment Co., Inc.·1976-11-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.