NDF

Product Code: NDF

Products Classified as NDF

4632

Plate, Fixation, Bone, Non-spinal, Metallic

Single/multiple Component Metallic Bone Fixation Appliances And Accessories.

Total Product Life Cycle (TPLC) Devices

4632

Plate, Fixation, Bone, Non-spinal, Metallic

Single/multiple Component Metallic Bone Fixation Appliances And Accessories.

FDA Consensus Standards

• Plate, Fixation, Bone, Non-Spinal, Metallic [37410]: 21 CFR §888.3030 🔎
• Plate, Fixation, Bone, Non-Spinal, Metallic [37411]: 21 CFR §888.3030 🔎

Pre-market Notifications for NDF

K051642	FR.O.H. CALCANEUS REPAIR SYSTEM	I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
K021749	EBI DYNAFIX VS OSTEOTOMY SYSTEM	EBI, L.P.
K010551	EBI DYNAFIX VS OSTEOTOMY SYSTEM	EBI, L.P.

Global Unique Device Identification Database

• 00880304552265: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304532144: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304506770: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304505612: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304498044: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304487482: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304486966: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304486690: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304486621: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00880304486089: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00889024054981: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00889024054950: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00889024054943: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00889024054929: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
• 00889024054868: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC

Maude Adverse Events

6.25MM VS PLATE 4-HOLE LEFT	BIOMET TRAUMA	2017-03-24
ZIMMER PERIARTICULAR HUMERAL PLATE	ZIMMER, INC.	2013-03-22
TORNIER	TORNIER INC.	2010-01-08
TORNIER STAYFUSE GREAT TOE INTERPHALANGEAL IM	TORNIER INC.	2009-10-22
*HARDWARE, ORTHOPEDIC, HIP PLATE	SMITH AND NEPHEW, INC.	2007-12-19
EBI DYNAFIX CORTICAL SCREW	EBI, L.P.	2006-08-24
*MANDIBULAR PLATE-LEVEL ONE	KLS MARTIN	2002-12-24
*MANDIBULAR PLATE - LEVEL ONE	KLS MARTIN	2002-12-24