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510(k) K001219

MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM by Biomedical Ent., Inc. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2000
Date Received
April 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Biomedical Ent., Inc.

  • K133844 — SPEED TRIAD (April 7, 2014)
  • K133780 — SPEED XL (March 19, 2014)
  • K131640 — SMOOTH OR THREADED METALLIC BONE FASTENER (October 16, 2013)
  • K102107 — OSSTAPLE CHILL (September 3, 2010)
  • K091951 — HAMMERLOCK (February 19, 2010)
  • K023203 — OSSTAPLE (October 17, 2002)
  • K001354 — MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR T (March 13, 2001)
  • K001353 — MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPL (March 13, 2001)
  • K993714 — MEMOGRAPH STAPLE, WARM SYSTEM (February 25, 2000)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)

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