FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JACOB WIRZ TRANSFIXATION PIN
K Number: K811209
·
Decision Jun 16, 1981
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
7
Review Days
46
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- JACOB WIRZ TRANSFIXATION PIN
- K Number
- K811209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Colmed, Ltd.
- Date Received
- May 1, 1981
- Decision Date
- June 16, 1981
- Product Code
- ELS
- 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 |
|---|---|---|---|
| ELS | Splint, Endodontic Stabilizing | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELS), ordered by most recent decision date.
SPLINT IT
FDA 510(k)
FDA Class 2
·Dental
MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING
FDA 510(k)
FDA Class 2
·Dental
ENDIX RADICULAR BIOCERAMIC PIN
FDA 510(k)
FDA Class 2
·Dental
ZEST ENDODONTIC STABILIZER
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Colmed, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K810636 | VARIODRAIN | May 1, 1981 | Substantially Equivalent |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Feb 10, 1981 | Substantially Equivalent |
| K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | May 28, 1980 | Substantially Equivalent |
| K801006 | CHARNLEY DESIGN HIP PROSTHESIS | May 20, 1980 | Substantially Equivalent |
| K800762 | PS3 TITANIUM SCREW DENTAL IMPLANT | May 14, 1980 | Substantially Equivalent |
| K792241 | PELIMIT | Nov 30, 1979 | Substantially Equivalent |