Product Code: HTZ
FDA class 1
21 CFR 878.4800
Instrument, Cutting, Orthopedic
General, Plastic Surgery
An orthopedic cutting instrument is a surgical tool designed specifically for cutting tissue or bone during orthopedic procedures, encompassing instruments used in general and plastic surgery contexts. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating low risk and general controls only. Product code HTZ falls under the General and Plastic Surgery medical specialty.
510(k)s
21
FEI Numbers
232
Registration Numbers
232
Unique Applicants
11
Years Active
17
Basic Information
- Product Code
- HTZ
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933933 | CEBOPLANE | Apr 15, 1994 | Substantially Equivalent | SYNVASIVE TECHNOLOGY, INC. |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | Jan 07, 1994 | Substantially Equivalent | SYNVASIVE TECHNOLOGY, INC. |
| K870882 | 45 DEGREE SHAVER | Mar 23, 1987 | Substantially Equivalent | BOWEN & COMPANY, INC. |
| K853678 | KAMBIN SPINAL INSTRUMENT SET | Sep 24, 1985 | Substantially Equivalent | PILLING CO. |
| K850527 | ARTHROSCOPY SUCTION BIOPSY PUNCH | Mar 14, 1985 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K850423 | CONCEPT SUCTION SLEEVE | Mar 14, 1985 | Substantially Equivalent | CONCEPT, INC. |
| K841980 | SIDE CUTTING SERRATED BLADE | Aug 15, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K842774 | CODMAN SUCTION PUNCH-PRODUCT CODES | Jul 27, 1984 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | Jun 19, 1984 | Substantially Equivalent | J. SKLAR MFG. CO., INC. |
| K841982 | MENISCOTOME 4MM & 5MM | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K841978 | LATERAL RELEASE KNIFE 5MM & 7MM | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K841977 | 5MM DOUGLE EDGE RING CURETTE | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K841976 | HOOK KNIFE 4MM & 5MM | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K841975 | ROSETTE KNIFE 4MM | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K841974 | RETROGRADE KNIFE 4MM & 5MM | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K841973 | BANANA KNIFE SERRATED | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K841972 | BANANA KNIFE - K841969-LABELING | Jun 19, 1984 | Substantially Equivalent | STAINLESS MFG., INC. |
| K831772 | GUILLOTINE BLADE | Jul 07, 1983 | Substantially Equivalent | ORTHO PARED INSTRUMENTS, INC. |
| K771915 | MICRO OSCILLATING SAW | Oct 21, 1977 | Substantially Equivalent | AMERICAN STERILIZER CO. |
| K771006 | MODIFIED PODIATRY PRODUCTS | Jun 17, 1977 | Substantially Equivalent | DENTRONIX INC. |
| K771005 | NEW PODIATRY PRODUCTS | Jun 17, 1977 | Substantially Equivalent | DENTRONIX INC. |
FEI Numbers
This FDA classification entry is associated with 232 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 232 registration numbers. Click on an entry to view related FDA registrations.