FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THREE SPIKE CUP
K Number: K922870
·
Decision Apr 8, 1993
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
18
Review Days
308
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Basic Information
- Device Name
- THREE SPIKE CUP
- K Number
- K922870
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3520
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteo Technology, Inc.
- Date Received
- June 4, 1992
- Decision Date
- April 8, 1993
- Product Code
- GRF
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GRF | Antiserum, Cf, Rubeola | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRF), ordered by most recent decision date.
View allOther Clearances by Osteo Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926156 | REPLICA(TM) TOTAL HIP SYSTEM | Mar 9, 1994 | Substantially Equivalent for Some Indications |
| K922859 | ANATOMICAL TYPE KNEE SYSTEM | Sep 23, 1993 | Substantially Equivalent |
| K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM | Jul 13, 1993 | Substantially Equivalent |
| K925447 | OTI ORTHOPEDIC WIRE SYSTEM | Jun 29, 1993 | Substantially Equivalent |
| K926213 | MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM | Jun 17, 1993 | Substantially Equivalent |
| K922861 | BIOMETRIC SCREW FIXATION CUP | May 12, 1993 | Substantially Equivalent |
| K922682 | AMERICANA HIP PROTHESIS | Mar 16, 1993 | Substantially Equivalent |
| K925301 | OTI ORTHOPEDIC FASTENER SYSTEM | Mar 16, 1993 | Substantially Equivalent |
| K922871 | UNIFIT FEMORAL STEM | Feb 12, 1993 | Substantially Equivalent |
| K922868 | THOMPSON TYPE HIP PROTHESIS | Feb 12, 1993 | Substantially Equivalent |