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

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

21 CFR 888.3030 / Orthopedic
FDA source (opens on fda.gov)

OBT is the FDA product code for Plate, Bone, Growth Control, Pediatric, Epiphysiodesis, a class II device type, regulated under 21 CFR 888.3030. FDA's definition for this code reads: "Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OBT
Device name
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
FDA definition
Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius). The device may be removed when growth has equalized or the growth plate has fused.
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
1

Clearances, product code OBT

By decision year
6 clearances under product code OBT with a decision year between 2010 and 2022, 2018 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OBT by decision year
YearClearances
20101
20111
20182
20191
20221

Applicants with the most clearances

Product code OBT
Applicants holding the most 510(k) clearances under product code OBT
ApplicantClearances
Orthofix SRL4
Orthopediatrics Canada ULC1
Wishbone Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order