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510(k) K870842

SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP by Warsaw Orthopedic, Inc. — Product Code HTP

K870842 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP". The FDA issued a decision of Substantially Equivalent on May 27, 1987. The device falls under product code HTP (File), a Class I device regulated under 21 CFR 888.4540. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1987
Date Received
March 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Warsaw Orthopedic, Inc.

  • K892877 — CRADLE, HOSPITAL BED CLOTHING (June 15, 1989)
  • K883783 — TSRH SACRAL SPINAL SCREW (April 6, 1989)
  • K883784 — TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE (April 6, 1989)
  • K880211 — TSRH H/M HOOK HOLDER (March 4, 1988)
  • K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER (March 4, 1988)
  • K880215 — TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD (February 18, 1988)
  • K880214 — TSRH H/M TORQUE LIMITING WRENCH (February 18, 1988)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K870830 — WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM (May 4, 1987)
  • K870844 — SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR (March 13, 1987)

Other clearances for product code HTP

  • K931733 — INTERMEDICS ORTHOPEDICS REAMERS (January 26, 1994)
  • K862659 — CONCEPT ARTHROSCOPY RASP (September 2, 1986)
  • K841981 — 4MM & 5MM FILE (June 19, 1984)
  • K840492 — SUN-LITE BLUE SLIT (May 9, 1984)

FDA data resources