HTZ — Instrument, Cutting, Orthopedic Class I
FDA product code HTZ covers "Instrument, Cutting, Orthopedic", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HTZ
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K933933 | synvasive technology | CEBOPLANE | April 15, 1994 |
| K931737 | synvasive technology | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | January 7, 1994 |
| K870882 | bowen and company | 45 DEGREE SHAVER | March 23, 1987 |
| K853678 | pilling | KAMBIN SPINAL INSTRUMENT SET | September 24, 1985 |
| K850527 | t. korossurgical instruments | ARTHROSCOPY SUCTION BIOPSY PUNCH | March 14, 1985 |
| K850423 | concept | CONCEPT SUCTION SLEEVE | March 14, 1985 |
| K841980 | stainless mfg | SIDE CUTTING SERRATED BLADE | August 15, 1984 |
| K842774 | codman and shurtleff | CODMAN SUCTION PUNCH-PRODUCT CODES | July 27, 1984 |
| K841975 | stainless mfg | ROSETTE KNIFE 4MM | June 19, 1984 |
| K841973 | stainless mfg | BANANA KNIFE SERRATED | June 19, 1984 |
| K841972 | stainless mfg | BANANA KNIFE - K841969-LABELING | June 19, 1984 |
| K841974 | stainless mfg | RETROGRADE KNIFE 4MM & 5MM | June 19, 1984 |
| K841978 | stainless mfg | LATERAL RELEASE KNIFE 5MM & 7MM | June 19, 1984 |
| K841977 | stainless mfg | 5MM DOUGLE EDGE RING CURETTE | June 19, 1984 |
| K842111 | j. sklar mfg. co | KOGAN ENDOSPECULUM 9-1/2 | June 19, 1984 |
| K841982 | stainless mfg | MENISCOTOME 4MM & 5MM | June 19, 1984 |
| K841976 | stainless mfg | HOOK KNIFE 4MM & 5MM | June 19, 1984 |
| K831772 | ortho pared instruments | GUILLOTINE BLADE | July 7, 1983 |
| K771915 | american sterilizer | MICRO OSCILLATING SAW | October 21, 1977 |
| K771005 | dentronix | NEW PODIATRY PRODUCTS | June 17, 1977 |