510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MRWUnclassified

System, Facet Screw Spinal Device

Unknown
FDA source (opens on fda.gov)

MRW is the FDA product code for System, Facet Screw Spinal Device. As of , FDA records hold 78 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
MRW
Device name
System, Facet Screw Spinal Device
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
79
Ingested recalls
4

Clearances, product code MRW

By decision year
79 clearances under product code MRW with a decision year between 1997 and 2026, 2013 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code MRW by decision year
YearClearances
19971
20002
20013
20022
20031
20054
20062
20083
20096
20106
20113
20124
20137
20152
20162
20171
20182
20193
20223
20233
20247
20257
20265

Applicants with the most clearances

Product code MRW
Applicants holding the most 510(k) clearances under product code MRW
ApplicantClearances
Providence Medical Technology, Inc.9
Surgentec LLC6
NuVasive Inc4
Triage Medical, Inc.4
Spinal Elements, Inc3
Globus Medical, Inc.3
Medtronic Sofamor Danek3
SC Medica3
Alphatec Spine, Inc.2
Facet-Link, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 92 companies shown, in name order