510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884688Substantially Equivalent for Some Indications

Modular Spinal Fixation & Locking Hook Spinal Rod

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

K884688 is the FDA 510(k) clearance record for MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD, a class II device, cleared for Synthes (Usa) on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show no recalls naming K884688.

Clearance record

Decision date
Received
(108 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
Third party review
No

Clearances, product code KWP

Trailing 12 months

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

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