510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780139Substantially Equivalent

Pneumatic Powered Bur

North Palm Beach Orthodepic Assoc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780139 is the FDA 510(k) clearance record for PNEUMATIC POWERED BUR, a class I device, cleared for North Palm Beach Orthodepic Assoc. on under FDA product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment). FDA records list one 510(k) clearance for North Palm Beach Orthodepic Assoc. As of , FDA records show no recalls naming K780139.

Clearance record

Decision date
Received
(5 days to decision)
Product code
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
North Palm Beach Orthodepic Assoc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HSZ

Trailing 12 months

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

FDA records show no clearances under product code HSZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HSZ, 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