Oti Orthopedic Wire System
FDA 510(k) K925447 · Osteo Technology, Inc.
510(k) numberK925447
Submission
- Device name
- Oti Orthopedic Wire System
- Applicant
- Osteo Technology, Inc.
Timonium, MD, US - Received
- October 28, 1992
- Decision date
- June 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|
| K926156 | Replica(Tm) Total Hip SystemLPH · Traditional | 03/09/1994SN |
| K922859 | Anatomical Type Knee SystemJWH · Traditional | 09/23/1993SE |
| K922869 | Total Condylat Type Knee SystemJWH · Traditional | 07/13/1993SE |
| K926213 | Modified Zickel Intramedullary Rod SystemHSB · Traditional | 06/17/1993SE |
| K922861 | Biometric Screw Fixation CupJDL · Traditional | 05/12/1993SE |
| K922870 | Three Spike CupGRF · Traditional | 04/08/1993SE |
| K925301 | Oti Orthopedic Fastener SystemHTY · Traditional | 03/16/1993SE |
| K922682 | Americana Hip ProthesisJDG · Traditional | 03/16/1993SE |
| K922871 | Unifit Femoral StemJDI · Traditional | 02/12/1993SE |
| K922868 | Thompson Type Hip ProthesisKWA · Traditional | 02/12/1993SE |
Questions and answers
When was Oti Orthopedic Wire System cleared by the FDA?
Oti Orthopedic Wire System (K925447) received a 510(k) decision of Substantially Equivalent on June 29, 1993, 244 days after the submission was received.
What is the product code of K925447?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.