510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931733Substantially Equivalent

Intermedics Orthopedics Reamers

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

K931733 is the FDA 510(k) clearance record for INTERMEDICS ORTHOPEDICS REAMERS, a class I device, cleared for Intermedics Orthopedics on under FDA product code HTP (File). FDA records list 108 510(k) clearances for Intermedics Orthopedics, from to . As of , FDA records show no recalls naming K931733.

Clearance record

Decision date
Received
(294 days to decision)
Product code
HTP File
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Intermedics Orthopedics 1300 E. Anderson Ln., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code HTP

Trailing 12 months

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

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