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510(k) K900405

SCHOLTEN FRAME by Scholten Surgical Instruments, Inc. — Product Code JEB

K900405 is an FDA 510(k) premarket notification submitted by Scholten Surgical Instruments, Inc. for the device "SCHOLTEN FRAME". The FDA issued a decision of Substantially Equivalent on March 1, 1990. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950. Scholten Surgical Instruments, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1990
Date Received
January 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Surgical With Orthopedic Accessories, Manual
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by Scholten Surgical Instruments, Inc.

  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K852331 — SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC (August 1, 1986)
  • K852119 — TEMPORARY PACEMAKER GROUND WIRE (September 15, 1985)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)
  • K852120 — FORCEPS, BIOPSY(NON RIGID) (July 2, 1985)
  • K852330 — RETRACTOR, SURGICAL (June 27, 1985)
  • K852329 — STAND, OPERATING ROOM (June 14, 1985)

Other clearances for product code JEB

  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K891917 — ORTHO-J, INC. BEK-JS-004 (May 26, 1989)
  • K891387 — WILLIAMS BELT & BOOT (May 23, 1989)
  • K881101 — K ORTHOPEDIC TABLE (April 6, 1988)
  • K880263 — OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION (March 15, 1988)
  • K873274 — PLASTER TABLE 1418 (September 17, 1987)
  • K873273 — ORTHOPAEDIC TABLE 1420 (September 17, 1987)
  • K873275 — EXTENSION TABLE 1417 (September 17, 1987)
  • K873276 — EXTENSION DEVICE 1416 (September 17, 1987)
  • K781082 — CAST BLOCK (July 7, 1978)

FDA data resources