Asnis Guided Screw Systems
FDA 510(k) K801969 · Howmedica Corp.
510(k) numberK801969
Submission
- Device name
- Asnis Guided Screw Systems
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- August 19, 1980
- Decision date
- August 27, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNC – Specula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNC
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|---|---|---|---|
| K022836 | Stephens Disposable SpeculumHNC · Traditional | Stephens Instruments | 11/01/2002SE |
| K981235 | OculostatHNC · Traditional | Laser Center Dev. Corp. | 07/15/1998SE |
| K964289 | Eye Fixation SpeculumHNC · Traditional | Eyefix, Inc. | 12/17/1996SE |
| K863989 | Thornton Titanium Speculum (Modified Barraquer)HNC · Traditional | Keeler Instruments, Inc. | 10/31/1986SE |
| K863664 | Ophthalmic Surgical SpeculumHNC · Traditional | Myocure, Inc. | 09/25/1986SE |
| K843196 | Visitec Eye SpeculumHNC · Traditional | Visitec Co. | 10/05/1984SE |
| K830430 | Eyelid SpeculumHNC · Traditional | Douglas C. Mckee & Co. | 06/10/1983SE |
| K760849 | Feldstein Blepharostomy Clip SquareHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760848 | Feldstein Blepharoplasty Clip RectanguHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760847 | Feldstein Blepharoplasty Clip Sharp PHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
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| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Asnis Guided Screw Systems cleared by the FDA?
Asnis Guided Screw Systems (K801969) received a 510(k) decision of Substantially Equivalent on August 27, 1980, 8 days after the submission was received.
What is the product code of K801969?
The FDA product code is HNC – Specula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.