Osteo Compression Hip Screw
FDA 510(k) K920037 · Osteo AG
510(k) numberK920037
Submission
- Device name
- Osteo Compression Hip Screw
- Applicant
- Osteo AG
Greenwood, SC, US - Received
- January 6, 1992
- Decision date
- March 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HRC – Sterilizer, Soft-Lens, Thermal, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
More from Osteo AG
| 510(k) | Device | Decision |
|---|---|---|
| K933340 | Osteo Interlocking-Compression NailHSB · Traditional | 06/30/1994SE |
| K922196 | Osteo Tibia NailHSB · Traditional | 07/23/1992SE |
| K922195 | Osteo Femoral NailHSB · Traditional | 07/23/1992SE |
| K922194 | Osteo Steinmann PinHTY · Traditional | 07/23/1992SE |
| K922193 | Osteo Kirschner WireHTY · Traditional | 07/23/1992SE |
| K920149 | Osteo Ex-Fi-ReJEC · Traditional | 04/09/1992SE |
| K914374 | Osteo Cerclage WireJDQ · Traditional | 12/30/1991SE |
| K913559 | Osteo Complete Pneumatic Drill-OscilairHSZ · Traditional | 11/07/1991SE |
Questions and answers
When was Osteo Compression Hip Screw cleared by the FDA?
Osteo Compression Hip Screw (K920037) received a 510(k) decision of Substantially Equivalent on March 11, 1992, 65 days after the submission was received.
What is the product code of K920037?
The FDA product code is HRC – Sterilizer, Soft-Lens, Thermal, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.5928.