510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K960514Substantially Equivalent

Tmp Mandibular Compression System (Modification)

Anspach Fixation Systems, Palm Beach Gardens FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960514 is the FDA 510(k) clearance record for TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION), a class II device, cleared for Anspach Fixation Systems on under FDA product code JEY (Plate, Bone). FDA records list one 510(k) clearance for Anspach Fixation Systems. As of , FDA records show no recalls naming K960514.

Clearance record

Decision date
Received
(81 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Anspach Fixation Systems 4500 Riverside Dr., Palm Beach Gardens FL
510(k) summary
Statement
Third party review
No

Clearances, product code JEY

Trailing 12 months
5 clearances under product code JEY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260