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510(k) K052294

SHOULDER NAIL PLATE by Hand Innovations, LLC — Product Code HRS

K052294 is an FDA 510(k) premarket notification submitted by Hand Innovations, LLC for the device "SHOULDER NAIL PLATE". The FDA issued a decision of Substantially Equivalent on October 21, 2005. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Hand Innovations, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2005
Date Received
August 23, 2005
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 Hand Innovations, LLC

  • K061748 — FRAGMENT PLATE SYSTEM (July 17, 2006)
  • K060864 — MULTIDIRECTIONAL THREADED PEG (April 28, 2006)
  • K060294 — DIAPHYSEAL PLATE (March 22, 2006)
  • K060290 — SHOULDER FIXATION SYSTEM (February 27, 2006)
  • K052248 — DORSAL NAIL PLATE, ANATOMICAL (September 14, 2005)
  • K051728 — MODIFICATION TO SHOULDER FIXATION SYSTEM (July 20, 2005)
  • K050932 — DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (April 26, 2005)
  • K042059 — SHOULDER FIXATION SYSTEM (September 30, 2004)
  • K041157 — MODIFICATION TO SMALL BONE FIXATION SYSTEM (July 30, 2004)
  • K041081 — FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES (July 1, 2004)

Other clearances for product code HRS

  • K262032 — TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fus (July 16, 2026)
  • K261191 — Alians Elbow S (July 8, 2026)
  • K261054 — RibPlate System (July 1, 2026)
  • K261351 — SALGINA 2.5mm Distal Radius System (June 26, 2026)
  • K260958 — I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with An (June 16, 2026)
  • K261207 — Exalta Proximal Tibia Plating System (June 12, 2026)
  • K260761 — APTUS Clavicle System 2.8 (June 5, 2026)
  • K261002 — Pectus Blu System (June 2, 2026)
  • K261038 — Xpert PFP (May 29, 2026)
  • K261145 — Avanti Distal Elbow ORIF System (May 9, 2026)

FDA data resources