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510(k) K955229

WRIGHT MEDICAL TECHNOLOGY SAWBLADES by Wrightmedicaltechnologyinc — Product Code GFA

K955229 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "WRIGHT MEDICAL TECHNOLOGY SAWBLADES". The FDA issued a decision of Substantially Equivalent on January 18, 1996. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1996
Date Received
November 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Saw, General & Plastic Surgery, Surgical
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

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  • K202815 — PROPHECY Preoperative Navigation Alignment System (March 10, 2021)
  • K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System (January 8, 2021)
  • K200507 — PRO-DENSE LoVisc Bone Graft Substitute (October 21, 2020)
  • K193067 — The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISIO (June 8, 2020)
  • K191393 — INFINITY Total Ankle System, INBONE Total Ankle System (August 22, 2019)
  • K190970 — PROSTEP™ TBI™ (Tailors Bunion Implant) System (August 13, 2019)
  • K183620 — PROSTEP TBC Implant System (June 6, 2019)

Other clearances for product code GFA

  • K971978 — GRAFT HARVESTING SAWBLADES (June 18, 1997)
  • K954483 — STRYKER SAGITTAL SAW ATTACHMENT (January 30, 1996)
  • K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (July 12, 1995)
  • K950403 — SURGICAL SAW BLADES (February 21, 1995)
  • K940501 — RE-SHARPENABLE SAW BLADES (June 28, 1994)
  • K933595 — BUR, SURGICAL, GENERAL & PLASTIC SURGERY (March 16, 1994)
  • K935391 — SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PA (February 24, 1994)
  • K934603 — SURGICAL SAW BLADES (February 22, 1994)
  • K931769 — SNAP OSCILLATING SAW (January 27, 1994)
  • K934390 — OSCILLATING BONE SAW BLADE, 6200 SERIES (January 26, 1994)

FDA data resources