510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010690Substantially Equivalent

Synthes Titanium Multi-Vector Distractor

Synthes (USA) Products LLC, Paoli PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010690 is the FDA 510(k) clearance record for SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR, a class II device, cleared for Synthes (Usa) on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 4 recalls naming K010690.

Clearance record

Decision date
Received
(71 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
510(k) summary
Summary
Third party review
No

Clearances, product code DZL

Trailing 12 months
1 clearance under product code DZL in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260