510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K992000Substantially Equivalent

Synthes Cranial Flap Tube Clamp

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

K992000 is the FDA 510(k) clearance record for SYNTHES CRANIAL FLAP TUBE CLAMP, a class II device, cleared for Synthes (Usa) on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show one recall naming K992000.

Clearance record

Decision date
Received
(35 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
510(k) summary
Summary
Third party review
No

Clearances, product code GXN

Trailing 12 months
6 clearances under product code GXN 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 GXN, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260