FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
DURETTE IMPLANT
K Number: K073293
·
Decision Mar 19, 2008
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
38
Applicant Total
12
Review Days
117
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
- DURETTE IMPLANT
- K Number
- K073293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oculo Plastik, Inc.
- Date Received
- November 23, 2007
- Decision Date
- March 19, 2008
- Product Code
- HPZ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPZ), ordered by most recent decision date.
EZYPOR
FDA 510(k)
FDA Class 2
·Ophthalmic
DURETTE OCULAR IMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
FDA 510(k)
FDA Class 2
·Ophthalmic
SILICONE SPHERES
FDA 510(k)
FDA Class 2
·Ophthalmic
ORBITAL RECONSTRUCTIVE IMPLANT II
FDA 510(k)
FDA Class 2
·Ophthalmic
EYE SPHERES
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Oculo Plastik, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112176 | SILICONE SPHERES | Sep 15, 2011 | Substantially Equivalent |
| K040689 | EYE SPHERE IMPLANTS | Jun 10, 2004 | Substantially Equivalent |
| K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT | May 5, 1994 | Substantially Equivalent |
| K915630 | OPHTIMPLANT | Mar 2, 1992 | Substantially Equivalent |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | May 22, 1990 | Substantially Equivalent |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | May 18, 1990 | Substantially Equivalent |
| K900928 | COX MALAR EMINENCE IMPLANTS | May 15, 1990 | Substantially Equivalent |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | May 15, 1990 | Substantially Equivalent |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | May 15, 1990 | Substantially Equivalent |
| K900080 | NEW IOWA MOTILITY IMPLANT | Mar 23, 1990 | Substantially Equivalent |