Three Spike Cup
FDA 510(k) K922870 · Osteo Technology, Inc.
510(k) numberK922870
Submission
- Device name
- Three Spike Cup
- Applicant
- Osteo Technology, Inc.
Timonium, MD, US - Received
- June 4, 1992
- Decision date
- April 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GRF – Antiserum, Cf, Rubeola
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3520
- Specialty
- Microbiology
Other 510(k)s with product code GRF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852932 | Measles-Complement Fix Antigen & Negative CLTGRF · Traditional | Microbix Biosystems, Inc. | 11/12/1985SE |
More from Microbix Biosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K925447 | Oti Orthopedic Wire SystemJDQ · Traditional | 06/29/1993SE |
| K926213 | Modified Zickel Intramedullary Rod SystemHSB · Traditional | 06/17/1993SE |
| K922861 | Biometric Screw Fixation CupJDL · Traditional | 05/12/1993SE |
| 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 Three Spike Cup cleared by the FDA?
Three Spike Cup (K922870) received a 510(k) decision of Substantially Equivalent on April 8, 1993, 308 days after the submission was received.
What is the product code of K922870?
The FDA product code is GRF – Antiserum, Cf, Rubeola, a Class I (low risk) device regulated under 21 CFR 866.3520.