Question 1

Who is the manufacturer of KINEMAX PLUS TIBIAL INSERT?

Accepted Answer

Howmedica Corp. filed the 510(k) submission for KINEMAX PLUS TIBIAL INSERT (K913188).

Question 2

What is the FDA product code for KINEMAX PLUS TIBIAL INSERT?

Accepted Answer

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

Question 3

When was KINEMAX PLUS TIBIAL INSERT cleared by the FDA?

Accepted Answer

Oct 11, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for KINEMAX PLUS TIBIAL INSERT?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like KINEMAX PLUS TIBIAL INSERT?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K913188
Device Name	KINEMAX PLUS TIBIAL INSERT
Applicant	Howmedica Corp.
Product Code	JWH · Orthopedic
Decision Date	Oct 11, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2

KINEMAX PLUS TIBIAL INSERT

Device Facts

Regulatory Classification

Identification