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 | Device Class | Medical Specialty |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Doctor'S Research Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051487 | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE | Dec 22, 2005 | Substantially Equivalent |
| K041018 | DRG SOFTRELEASE | Oct 18, 2004 | Substantially Equivalent |
| K012535 | DRG DISPOSABLE VAGINAL SPECULUM | Mar 1, 2002 | Substantially Equivalent |
| K012003 | DRG REACTION CHAMBER/SAFETY TIP | Feb 12, 2002 | Substantially Equivalent |
| K011736 | DRG QUICKMIX | Jan 30, 2002 | Substantially Equivalent |
| K013786 | DRG ORTHOHEX SS BONE SCREW | Dec 17, 2001 | Substantially Equivalent |
| K002047 | DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 | Nov 22, 2000 | Substantially Equivalent |
| K991714 | DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 | Dec 10, 1999 | Substantially Equivalent |
| K990212 | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 | Sep 14, 1999 | Substantially Equivalent |
| K981881 | DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING | Dec 2, 1998 | Substantially Equivalent |