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510(k) K131640

SMOOTH OR THREADED METALLIC BONE FASTENER by Biomedical Ent., Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2013
Date Received
June 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Biomedical Ent., Inc.

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  • 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)
  • K001219 — MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPL (June 21, 2000)
  • K993714 — MEMOGRAPH STAPLE, WARM SYSTEM (February 25, 2000)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)

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