Product code HTZ
- Device name
- Instrument, Cutting, Orthopedic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933933 | CEBOPLANE | Synvasive Technology, Inc. | 1994-04-15 |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | Synvasive Technology, Inc. | 1994-01-07 |
| K870882 | 45 DEGREE SHAVER | Bowen & Company, Inc. | 1987-03-23 |
| K853678 | KAMBIN SPINAL INSTRUMENT SET | Pilling Co. | 1985-09-24 |
| K850527 | ARTHROSCOPY SUCTION BIOPSY PUNCH | T. Korossurgical Instruments Corp. | 1985-03-14 |
| K850423 | CONCEPT SUCTION SLEEVE | Concept, Inc. | 1985-03-14 |
| K841980 | SIDE CUTTING SERRATED BLADE | Stainless Mfg., Inc. | 1984-08-15 |
| K842774 | CODMAN SUCTION PUNCH-PRODUCT CODES | Codman & Shurtleff, Inc. | 1984-07-27 |
| K841978 | LATERAL RELEASE KNIFE 5MM & 7MM | Stainless Mfg., Inc. | 1984-06-19 |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | J. Sklar Mfg. Co., Inc. | 1984-06-19 |
| K841982 | MENISCOTOME 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 |
| K841977 | 5MM DOUGLE EDGE RING CURETTE | Stainless Mfg., Inc. | 1984-06-19 |
| K841976 | HOOK KNIFE 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 |
| K841975 | ROSETTE KNIFE 4MM | Stainless Mfg., Inc. | 1984-06-19 |
| K841974 | RETROGRADE KNIFE 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 |
| K841973 | BANANA KNIFE SERRATED | Stainless Mfg., Inc. | 1984-06-19 |
| K841972 | BANANA KNIFE - K841969-LABELING | Stainless Mfg., Inc. | 1984-06-19 |
| K831772 | GUILLOTINE BLADE | Ortho Pared Instruments, Inc. | 1983-07-07 |
| K771915 | MICRO OSCILLATING SAW | American Sterilizer Co. | 1977-10-21 |
| K771005 | NEW PODIATRY PRODUCTS | Dentronix, Inc. | 1977-06-17 |
| K771006 | MODIFIED PODIATRY PRODUCTS | Dentronix, Inc. | 1977-06-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07649988948718 | SPIRECUT | SPIRECUT SA | 2026-05-04 |
| 07649988948701 | SPIRECUT | SPIRECUT SA | 2026-05-04 |
| 07898506849413 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506849420 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506848959 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506841752 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506841714 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506841707 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506841677 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506814114 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506814107 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506841691 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506841684 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 07898506838943 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 07898506842148 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 07898506848072 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 07898506814329 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 10381780241348 | Ascension® | Ascension Orthopedics, Inc. | 2018-09-12 |
| 10381780167716 | Ascension® | Ascension Orthopedics, Inc. | 2018-09-11 |
| 10381780183754 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-27 |
| 10381780212317 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-27 |
| 10381780212300 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-27 |
| 10381780183785 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-27 |
| 10381780183778 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-27 |
| 10381780183761 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-27 |
| 10381780183747 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-27 |
| 10381780242826 | NuGrip® CMC Implant System | Ascension Orthopedics, Inc. | 2017-09-29 |
| 10381780237167 | Integra® NuGrip® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780237174 | Integra® NuGrip® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780237181 | Integra® NuGrip® | Ascension Orthopedics, Inc. | 2016-08-15 |