Question 1

Who is the manufacturer of LSF ANATOMIC CEMENTED HIP?

Accepted Answer

Osteo Technology, Inc. filed the 510(k) submission for LSF ANATOMIC CEMENTED HIP (K922645).

Question 2

What is the FDA product code for LSF ANATOMIC CEMENTED HIP?

Accepted Answer

JDI. It is classified under 21 CFR 888.3350 as a Class 2 device in the Orthopedic panel.

Question 3

When was LSF ANATOMIC CEMENTED HIP cleared by the FDA?

Accepted Answer

Jan 7, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for LSF ANATOMIC CEMENTED HIP?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LSF ANATOMIC CEMENTED HIP?

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	K922645
Device Name	LSF ANATOMIC CEMENTED HIP
Applicant	Osteo Technology, Inc.
Product Code	JDI · Orthopedic
Decision Date	Jan 7, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2

LSF ANATOMIC CEMENTED HIP

Device Facts

Regulatory Classification

Identification