LUMBAR IMPACTION SET

Appliance, Fixation, Spinal Interlaminal

T. KOROS SURGICAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by T. Koros Surgical Instruments Corp. with the FDA for Lumbar Impaction Set.

Pre-market Notification Details

• Device ID: K875290
• 510k Number: K875290
• Device Name: LUMBAR IMPACTION SET
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021
• Contact: Tibor Koros
• Correspondent: Tibor Koros; T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-12-30
• Decision Date: 1988-03-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10840199500557	K875290	000
10840199500250	K875290	000
10840199500243	K875290	000
10840199500236	K875290	000
10840199500229	K875290	000
10840199500212	K875290	000
10840199500205	K875290	000
10840199500199	K875290	000
10840199500182	K875290	000
10840199500168	K875290	000
10840199500151	K875290	000
10840199500144	K875290	000
10840199500137	K875290	000
10840199500120	K875290	000
00840199500321	K875290	000
00840199500338	K875290	000
00840199500284	K875290	000
10840199500267	K875290	000
10840199500298	K875290	000
10840199500304	K875290	000
10840199500519	K875290	000
00840199527229	K875290	000
10840199500601	K875290	000
10840199500595	K875290	000
10840199500588	K875290	000
10840199500571	K875290	000
10840199500564	K875290	000
10840199500540	K875290	000
10840199500533	K875290	000
10840199500526	K875290	000
10840199500502	K875290	000
10840199500496	K875290	000
10840199500366	K875290	000
10840199500359	K875290	000
10840199500342	K875290	000
10840199500311	K875290	000
00840199500277	K875290	000