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510(k) K081588

RE-ZORB PLATING SYSTEM by Acute Innovations, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2008
Date Received
June 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Acute Innovations, LLC

  • K120163 — ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM (February 17, 2012)
  • K113318 — ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM (January 12, 2012)
  • K101170 — ACUTE INNOVATIONS STERNAL FIXATION SYSTEM (September 17, 2010)
  • K061206 — ACUTE BONE SCREW (June 19, 2006)

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  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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