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510(k) K870668

DRIVER-BENDER-EXTRACTOR, BONE PIN by Military Engineering, Inc. — Product Code HXW

K870668 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "DRIVER-BENDER-EXTRACTOR, BONE PIN". The FDA issued a decision of Substantially Equivalent on March 9, 1987. The device falls under product code HXW (Bender), a Class I device regulated under 21 CFR 888.4540. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1987
Date Received
February 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Military Engineering, Inc.

  • K874335 — EXPLORER-DENTAL PROBER (December 29, 1987)
  • K873715 — BONE PIN CUTTER 18 (October 28, 1987)
  • K872842 — PIN, HIP, KNOWLES (August 7, 1987)
  • K872091 — CURRETTES, ALVEOLAR (MOLT AND MILLER) (July 31, 1987)
  • K871834 — DRILL, HAND, BONE, SMEDBERG (July 31, 1987)
  • K872738 — CORTICAL BONE SCREWS (July 30, 1987)
  • K872609 — CURETTE SET, ANTRUM, COAKLEY (July 15, 1987)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K872092 — OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (June 23, 1987)
  • K870590 — CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY (April 16, 1987)

Other clearances for product code HXW

  • K872949 — ACROMED BONE PLATE BENDER (October 15, 1987)
  • K870084 — RD 140 SURGICAL BENDER (January 28, 1987)

FDA data resources