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

Spinous Process Plate

21 CFR 888.3050 / Orthopedic
FDA source (opens on fda.gov)

PEK is the FDA product code for Spinous Process Plate, a class II device type, regulated under 21 CFR 888.3050. FDA's definition for this code reads: "A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back...". As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PEK
Device name
Spinous Process Plate
FDA definition
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.
Regulation
21 CFR 888.3050
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
48
Ingested recalls
1

Clearances, product code PEK

By decision year
48 clearances under product code PEK with a decision year between 2013 and 2025, 2013 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code PEK by decision year
YearClearances
201310
20148
20156
20164
20173
20184
20202
20212
20223
20234
20241
20251

Applicants with the most clearances

Product code PEK
Applicants holding the most 510(k) clearances under product code PEK
ApplicantClearances
Spinal Simplicity, LLC10
Aurora Spine, Inc.4
Globus Medical, Inc.3
Precision Spine, Inc.3
Dio Medical Co., Ltd.2
Nu Vasive, Incorporated2
NuVasive Inc2
Paradigm Spine GmbH2
Amplio Spine1
Innovasis, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order