FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

DRG TITANIUM BONE PLATE

K Number: K990920 · Decision Jun 10, 1999
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
13
Review Days
84

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Basic Information

Device Name
DRG TITANIUM BONE PLATE
K Number
K990920
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.4760
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Doctor'S Research Group, Inc.
Date Received
March 18, 1999
Decision Date
June 10, 1999
Product Code
JEY
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JEY Plate, Bone

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Other Clearances by Doctor'S Research Group, Inc.

K Number Device Name
K051487 DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
K041018 DRG SOFTRELEASE
K012535 DRG DISPOSABLE VAGINAL SPECULUM
K012003 DRG REACTION CHAMBER/SAFETY TIP
K011736 DRG QUICKMIX
K013786 DRG ORTHOHEX SS BONE SCREW
K002047 DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
K991714 DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
K990212 LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
K981881 DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
Search all 13 clearances from Doctor'S Research Group, Inc. →