Ortho-Level

FDA 510(k) K822305 · Frontier Products

Substantially Equivalent

510(k) numberK822305

Submission

Device name
Ortho-Level
Applicant
Frontier Products
Mchenry, IL, US
Received
July 27, 1982
Decision date
August 20, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTH – Protractor
Device class
Class I (low risk)
Regulation
21 CFR 888.4600
Specialty
Orthopedic

Other 510(k)s with product code HTH

510(k)DeviceApplicantDecision
K861576Shortening Osteotomy GuideHTH · Traditional Osteotomy Guide Co.05/12/1986SE
K841470Reese Osteotomy Guide SysHTH · Traditional Osteotomy Guide Co.05/23/1984SE

More from Osteotomy Guide Co.

510(k)DeviceDecision
K831001Unicuff-Blood Pressure CuffDXQ · Traditional 07/28/1983SE
K812639UnicuffDXP · Traditional 10/02/1981SE
K801099Unicuf, Blood Pressure CuffDXQ · Traditional 05/30/1980SE

Questions and answers

When was Ortho-Level cleared by the FDA?

Ortho-Level (K822305) received a 510(k) decision of Substantially Equivalent on August 20, 1982, 24 days after the submission was received.

What is the product code of K822305?

The FDA product code is HTH – Protractor, a Class I (low risk) device regulated under 21 CFR 888.4600.