510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K063606Substantially Equivalent

Modification to Staxx Fx System

Spine Wave Inc, Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063606 is the FDA 510(k) clearance record for MODIFICATION TO STAXX FX SYSTEM, a class II device, cleared for Spine Wave, Inc. on under FDA product code OBL (Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty). FDA's definition for product code OBL reads: "Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height". FDA records list 59 510(k) clearances for Spine Wave, Inc., from to . As of , FDA records show no recalls naming K063606.

Clearance record

Decision date
Received
(133 days to decision)
Product code
OBL Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Spine Wave, Inc. Two Enterprise Dr., Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBL

Trailing 12 months

FDA records hold no clearances under product code OBL in the trailing twelve months.

FDA records show no clearances under product code OBL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OBL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260