FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAVERNETTI-TENNANT
K Number: K760744
·
Decision Oct 7, 1976
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
90
Applicant Total
39
Review Days
7
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TAVERNETTI-TENNANT
- K Number
- K760744
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3530
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Cutter Laboratories, Inc.
- Date Received
- September 30, 1976
- Decision Date
- October 7, 1976
- Product Code
- HRY
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRY), ordered by most recent decision date.
SIGMA High Performance (HP) Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
NanoOrtho NanoKnee® System
FDA 510(k)
FDA Class 2
·Orthopedic
MPO Total Knee Systems MR Labeling
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORIS POROUS PARTIAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
FDA 510(k)
FDA Class 2
·Orthopedic
UNIVATION
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Cutter Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861315 | HYPERBARIC PENETRATION EXTENSION SET | May 21, 1986 | Substantially Equivalent |
| K854106 | BAYSILEX | Mar 17, 1986 | Substantially Equivalent |
| K842324 | PERFOURM | Nov 9, 1984 | Substantially Equivalent |
| K834106 | INTRAVENOUS INFUSION CONTROLLER | May 30, 1984 | Substantially Equivalent |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | Aug 16, 1983 | Substantially Equivalent |
| K823214 | DOSIMETRIC RELEASE PROGRAM - ADMIN. SET | Jan 12, 1983 | Substantially Equivalent |
| K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT | May 28, 1982 | Substantially Equivalent |
| K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT | Mar 2, 1982 | Substantially Equivalent |
| K802105 | C-BLADE | Sep 16, 1980 | Substantially Equivalent |
| K802104 | C-SPLINT | Sep 16, 1980 | Substantially Equivalent |