HWT · Template
Orthopedic · 21 CFR 888.4800 · Class 1
Overview
| Product Code | HWT |
|---|---|
| Device Name | Template |
| Regulation | 21 CFR 888.4800 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974406 | ORTHOPLAN | Ortho-Graphics, Inc. | Feb 18, 1998 | SESE |
| K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Integrated Surgical Systems, Inc. | Jan 17, 1997 | SESE |
| K894228 | KRONNER SPHERICAL CUTTERS | Kronner Medical | Jul 23, 1990 | SESE |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | Warsaw Orthopedic, Inc. | May 27, 1987 | SESE |
| K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | Orthopedic Systems, Inc. | May 1, 1987 | SESE |
| K830360 | 3M OSTEOTOMY GUIDE | 3M Company | Mar 1, 1983 | SESE |
| K811205 | MOLDED POLYSULFONE TRIAL PROSTHESIS | Shannon Group | May 21, 1981 | SESE |
| K781091 | KNEE INSTRUMENTATION, CONDYLAR | Biomet, Inc. | Jul 17, 1978 | SESE |
| K771710 | WORRELL PATELLA TEMPLATE | Depuy, Inc. | Oct 6, 1977 | SESE |
| K771709 | WORRELL TRIAL PATELLA | Depuy, Inc. | Oct 6, 1977 | SESE |
Top Applicants
- Depuy, Inc. — 2 clearances
- Warsaw Orthopedic, Inc. — 1 clearance
- Shannon Group — 1 clearance
- Orthopedic Systems, Inc. — 1 clearance
- Ortho-Graphics, Inc. — 1 clearance
