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

Bone Cement, Posterior Screw Augmentation

21 CFR 888.3027 / Orthopedic
FDA source (opens on fda.gov)

PML is the FDA product code for Bone Cement, Posterior Screw Augmentation, a class II device type, regulated under 21 CFR 888.3027. FDA's definition for this code reads: "The device is intended to augment the fixation of screws in a posterior spinal system construct". As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PML
Device name
Bone Cement, Posterior Screw Augmentation
FDA definition
The device is intended to augment the fixation of screws in a posterior spinal system construct.
Regulation
21 CFR 888.3027
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
19
Ingested recalls
2

Clearances, product code PML

By decision year
19 clearances under product code PML with a decision year between 2016 and 2026, 2020 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PML by decision year
YearClearances
20162
20171
20182
20192
20203
20211
20222
20233
20241
20262

Applicants with the most clearances

Product code PML
Applicants holding the most 510(k) clearances under product code PML
ApplicantClearances
Icotec AG2
Medtronic, Inc.2
Neo Medical, Inc.2
Alphatec Spine, Inc.1
Astura Medical1
CarboFix Orthopedics Inc.1
Globus Medical, Inc.1
Medacta International SA1
Medos International SARL1
Medtronic Sofamor Danek USA Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 70 companies shown, in name order