FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASNIS GUIDED SCREW SYSTEMS
K Number: K801969
·
Decision Aug 27, 1980
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
10
Applicant Total
373
Review Days
8
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
- ASNIS GUIDED SCREW SYSTEMS
- K Number
- K801969
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Howmedica Corp.
- Date Received
- August 19, 1980
- Decision Date
- August 27, 1980
- Product Code
- HNC
- 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 |
|---|---|---|---|
| HNC | Specula, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNC), ordered by most recent decision date.
STEPHENS DISPOSABLE SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
OCULOSTAT
FDA 510(k)
FDA Class 1
·Ophthalmic
EYE FIXATION SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
FDA 510(k)
FDA Class 1
·Ophthalmic
OPHTHALMIC SURGICAL SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
VISITEC EYE SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Howmedica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983528 | MICRO DYNAMIC MESH | Dec 23, 1998 | Substantially Equivalent |
| K983404 | TYPE 3 FEMORAL COMPONENTS | Dec 22, 1998 | Substantially Equivalent |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K983419 | HOFFMANN II MIAMI POST | Nov 25, 1998 | Substantially Equivalent |
| K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Nov 20, 1998 | Substantially Equivalent |
| K982873 | ZETA MULTIZONE SCN LOCKING NAIL | Oct 21, 1998 | Substantially Equivalent |
| K982531 | HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM | Oct 16, 1998 | Substantially Equivalent |