510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K102438Substantially Equivalent

Primalok Facet Fixation System

Osteomed, Chesterland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102438 is the FDA 510(k) clearance record for PRIMALOK FACET FIXATION SYSTEM, cleared for Osteomed LP on under FDA product code MRW (System, Facet Screw Spinal Device). FDA records list 73 510(k) clearances for Osteomed LP, from to . As of , FDA records show one recall naming K102438.

Clearance record

Decision date
Received
(35 days to decision)
Product code
MRW System, Facet Screw Spinal Device
Device class
Unclassified
Review panel
Unknown
Applicant
Osteomed LP 8202 Sherman Rd., Chesterland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRW

Trailing 12 months
7 clearances under product code MRW 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 MRW, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260