OBT

Product Code: OBT


Products Classified as OBT

4655Plate, Bone, Growth Control, Pediatric, EpiphysiodesisSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

Total Product Life Cycle (TPLC) Devices

4655Plate, Bone, Growth Control, Pediatric, EpiphysiodesisSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

FDA Consensus Standards

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis [37410]21 CFR §888.3030 🔎
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis [37411]21 CFR §888.3030 🔎

Pre-market Notifications for OBT

K220190The GIRO Growth Modulation SystemPega Medical, Inc.
K182704WishBone Guided Growth SystemWishBone Medical
K180624Guided Growth Plate System PlusOrthofix Srl
K172183Guided Growth Plate System PlusOrthofix Srl
K110805GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)ORTHOFIX INC.
K093442GUIDED GROWTH SYSTEMORTHOFIX INC.

Global Unique Device Identification Database

18056099649674Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518464Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518457Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518440Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518433Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518426Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518419Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518402Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518365Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518358Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518341Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518334Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518327Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518150Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
18054242518143Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Maude Adverse Events

GUIDED GROWTH SYSTEM EIGHT PLATE, QUAD-PLATEORTHOFIX INC.2015-01-28
EIGHT-PLATE GUIDED GROWTH SYSTEMORTHOFIX INC2011-08-04
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