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510(k) K001353

MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM by Biomedical Ent., Inc. — Product Code HBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2001
Date Received
April 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Plate, Cranioplasty
Device Class
Class II
Regulation Number
882.5360
Review Panel
NE
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)
  • 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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  • K171152 — Stryker Universal Neuro III System AXS Screw (May 19, 2017)
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  • K141385 — DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (March 27, 2015)
  • K101835 — MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (December 3, 2010)