Question 1

Who is the manufacturer of SPINAL SURGERY FRAME?

Accepted Answer

T. Korossurgical Instruments Corp. filed the 510(k) submission for SPINAL SURGERY FRAME (K875291).

Question 2

What is the FDA product code for SPINAL SURGERY FRAME?

Accepted Answer

BWN. It is classified under 21 CFR 878.4950 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was SPINAL SURGERY FRAME cleared by the FDA?

Accepted Answer

Jan 22, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for SPINAL SURGERY FRAME?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SPINAL SURGERY FRAME?

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	K875291
Device Name	SPINAL SURGERY FRAME
Applicant	T. Korossurgical Instruments Corp.
Product Code	BWN · General, Plastic Surgery
Decision Date	Jan 22, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4950
Device Class	Class 1

SPINAL SURGERY FRAME

Device Facts

Regulatory Classification

Identification