510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874911Substantially Equivalent

Mccain Instrument Tmj/sm. Joint Arthroscopic Surg

Biomet Microfixation, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874911 is the FDA 510(k) clearance record for MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG, a class II device, cleared for Walter Lorenz Surgical, Inc. on under FDA product code HRX (Arthroscope). FDA's definition for product code HRX reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 86 510(k) clearances for BIOMET MICROFIXATION, from to . As of , FDA records show no recalls naming K874911.

Clearance record

Decision date
Received
(84 days to decision)
Product code
HRX Arthroscope
Regulation
21 CFR 888.1100
Device class
Class II
Review panel
Orthopedic
Applicant
Walter Lorenz Surgical, Inc. 1520 Tradeport Dr., Jacksonville FL
Third party review
No

Clearances, product code HRX

Trailing 12 months
11 clearances under product code HRX in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code HRX, trailing twelve months
MonthClearances
November 20252
December 20252
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20262
September 20260
October 20262