Template
An orthopedic template is a reference guide or overlay tool used during preoperative planning or intraoperative measurement to determine the correct size and position of implants such as prosthetic components or fixation hardware. It is classified as an FDA Class 1 device under 21 CFR 888.4800, indicating minimal risk and general controls only. Product code HWT falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HWT
- Device Class
- FDA class 1
- Regulation Number
- 888.4800
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974406 | ORTHOPLAN | Feb 18, 1998 | Substantially Equivalent | Ortho-Graphics, Inc. |
| K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Jan 17, 1997 | Substantially Equivalent | Integrated Surgical Systems, Inc. |
| K894228 | KRONNER SPHERICAL CUTTERS | Jul 23, 1990 | Substantially Equivalent | Kronner Medical |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | May 27, 1987 | Substantially Equivalent | Warsaw Orthopedic, Inc. |
| K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | May 01, 1987 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K830360 | 3M OSTEOTOMY GUIDE | Mar 01, 1983 | Substantially Equivalent | 3M Company |
| K811205 | MOLDED POLYSULFONE TRIAL PROSTHESIS | May 21, 1981 | Substantially Equivalent | Shannon Group |
| K781091 | KNEE INSTRUMENTATION, CONDYLAR | Jul 17, 1978 | Substantially Equivalent | Biomet, Inc. |
| K771710 | WORRELL PATELLA TEMPLATE | Oct 06, 1977 | Substantially Equivalent | Depuy, Inc. |
| K771709 | WORRELL TRIAL PATELLA | Oct 06, 1977 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 434 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 434 registration numbers. Click on an entry to view related FDA registrations.