510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K001323Substantially Equivalent

Nuvasive Percutaneous Transfacet/intrapedicular Screw

NuVasive Inc, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001323 is the FDA 510(k) clearance record for NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW, cleared for Nuvasive, Inc. on under FDA product code MRW (System, Facet Screw Spinal Device). FDA records list 92 510(k) clearances for Nuvasive, Inc., from to . As of , FDA records show no recalls naming K001323.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MRW System, Facet Screw Spinal Device
Device class
Unclassified
Review panel
Unknown
Applicant
Nuvasive, Inc. 10065 Old Grove Rd., San Diego CA
510(k) summary
Summary
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