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510(k) K001354

MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM by Biomedical Ent., Inc. — Product Code JDR

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
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
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)
  • 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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  • K243658 — TMC Compression Implant System (December 26, 2024)
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  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
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