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510(k) K931692

T-PLATE by Onyx Medical Corp. — Product Code HRS

K931692 is an FDA 510(k) premarket notification submitted by Onyx Medical Corp. for the device "T-PLATE". The FDA issued a decision of SN on May 4, 1994. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Onyx Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 4, 1994
Date Received
April 5, 1993
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 Onyx Medical Corp.

  • K041679 — COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT (December 16, 2004)
  • K942022 — FACE-IT SHIELD (July 8, 1994)
  • K931690 — SPOON PLATE (June 7, 1994)
  • K931680 — CANNULATED CANCELLOUS SCREW (May 4, 1994)
  • K934614 — MINI FRAGMENT PLATE (May 4, 1994)
  • K931684 — EPIPHYSIS PLATE (May 4, 1994)
  • K931681 — CANNULATED NAVICULAR SCREW (April 25, 1994)
  • K931687 — MULTIPLE FRAGMENT PLATE (April 25, 1994)
  • K934616 — CANCELLOUS BONE SCREW (April 25, 1994)
  • K931694 — 1/4 TUBULAR PLATE (April 25, 1994)

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