510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K031657Substantially Equivalent

Stryker Spine Oasys Bone Screw

Howmedica Osteonics Corp, Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031657 is the FDA 510(k) clearance record for STRYKER SPINE OASYS BONE SCREW, cleared for Howmedica Osteonics Corp. on under FDA product code MRW (System, Facet Screw Spinal Device). FDA records list 377 510(k) clearances for Howmedica Osteonics Corp., from to . As of , FDA records show no recalls naming K031657.

Clearance record

Decision date
Received
(86 days to decision)
Product code
MRW System, Facet Screw Spinal Device
Device class
Unclassified
Review panel
Unknown
Applicant
Howmedica Osteonics Corp. 59 Rte. 17 S., Allendale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRW

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