ASNIS GUIDED SCREW SYSTEMS
FDA 510(k) clearance K801969 · decided 1980-08-27
Clearance details
- K-number
- K801969
- Device name
- ASNIS GUIDED SCREW SYSTEMS
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-19
- Decision date
- 1980-08-27
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- HNC
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| OCULOSTAT (K981235) | Laser Center Dev. Corp. | 1998-07-15 |
| EYE FIXATION SPECULUM (K964289) | Eyefix, Inc. | 1996-12-17 |
| THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (K863989) | Keeler Instruments, Inc. | 1986-10-31 |
| OPHTHALMIC SURGICAL SPECULUM (K863664) | Myocure, Inc. | 1986-09-25 |
| VISITEC EYE SPECULUM (K843196) | Visitec Co. | 1984-10-05 |
| EYELID SPECULUM (K830430) | Douglas C. Mckee & Co. | 1983-06-10 |
| FELDSTEIN BLEPHAROPLASTY CLIP SHARP P (K760847) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
| FELDSTEIN BLEPHAROSTOMY CLIP SQUARE (K760849) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
| FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (K760848) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |