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510(k) K875291

SPINAL SURGERY FRAME by T. Korossurgical Instruments Corp. — Product Code BWN

K875291 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "SPINAL SURGERY FRAME". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1988
Date Received
December 30, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by T. Korossurgical Instruments Corp.

  • K001915 — GRAFT MARKER RING (April 27, 2001)
  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K954016 — VIDEOSCOPE W/IRRIGATION SHEATH (January 25, 1996)
  • K953998 — DISCETOME TISSUE ASPIRATOR (December 4, 1995)
  • K954052 — ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES (November 6, 1995)
  • K954014 — PERCUTANEOUS DISCECTOMY CANNULA SYSTEM (November 6, 1995)
  • K935529 — CERVICAL SELF-RETAINING RETRACTOR (March 22, 1994)
  • K926583 — REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR (August 6, 1993)
  • K926585 — THOROCOSCOPY SELF-RETAINING RETRACTOR (August 6, 1993)
  • K931262 — REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR (August 6, 1993)

Other clearances for product code BWN

  • K942699 — AIRFRAME SURGICAL DRAPE SUPPORT (July 13, 1994)
  • K935441 — INFINITECH BREATH EZ (February 7, 1994)
  • K925005 — ISI SELF-SUPPORTING ARM (April 29, 1993)
  • K922288 — HOLDER, PEDIATRIC POSITION (February 10, 1993)
  • K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (April 2, 1991)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K884558 — IOP ADJUSTABLE STIRRUP (November 17, 1988)
  • K873272 — ENDOSCOPY TABLE 1532 ENDOSTAR (September 8, 1987)
  • K860177 — ALLEN UNIVERSAL STIRRUP (February 11, 1986)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)

FDA data resources