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
PHMClass II

Intervertebral Fusion Device With Bone Graft, Thoracic

21 CFR 888.3080 / Orthopedic
FDA source (opens on fda.gov)

PHM is the FDA product code for Intervertebral Fusion Device With Bone Graft, Thoracic, a class II device type, regulated under 21 CFR 888.3080. FDA's definition for this code reads: "Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PHM
Device name
Intervertebral Fusion Device With Bone Graft, Thoracic
FDA definition
Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PHM

By decision year
3 clearances under product code PHM with a decision year between 2015 and 2018, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PHM by decision year
YearClearances
20151
20161
20181

Applicants with the most clearances

Product code PHM
Applicants holding the most 510(k) clearances under product code PHM
ApplicantClearances
Alphatec Spine, Inc.2
Nu Vasive, Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 71 companies shown, in name order