510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K931734Substantially Equivalent

Intermedics Orthopedics Drill Bits

Intermedics Orthopedics, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931734 is the FDA 510(k) clearance record for INTERMEDICS ORTHOPEDICS DRILL BITS, a class I device, cleared for Intermedics Orthopedics on under FDA product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment). FDA records list 108 510(k) clearances for Intermedics Orthopedics, from to . As of , FDA records show no recalls naming K931734.

Clearance record

Decision date
Received
(321 days to decision)
Product code
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Intermedics Orthopedics 1300 E. Anderson Ln., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code HWE

Trailing 12 months

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

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