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 |
| K850423 | CONCEPT SUCTION SLEEVE | Concept, Inc. | 1985-03-14 |
| K850527 | ARTHROSCOPY SUCTION BIOPSY PUNCH | T. Korossurgical Instruments Corp. | 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 |
| K841972 | BANANA KNIFE - K841969-LABELING | Stainless Mfg., Inc. | 1984-06-19 |
| K841973 | BANANA KNIFE SERRATED | Stainless Mfg., Inc. | 1984-06-19 |
| K841974 | RETROGRADE KNIFE 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 |
| K841975 | ROSETTE KNIFE 4MM | Stainless Mfg., Inc. | 1984-06-19 |
| K841976 | HOOK KNIFE 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 |
| K841977 | 5MM DOUGLE EDGE RING CURETTE | Stainless Mfg., Inc. | 1984-06-19 |
| K841978 | LATERAL RELEASE KNIFE 5MM & 7MM | Stainless Mfg., Inc. | 1984-06-19 |
| K841982 | MENISCOTOME 4MM & 5MM | Stainless Mfg., Inc. | 1984-06-19 |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | J. Sklar Mfg. Co., 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 |
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| 03701089540780 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527859 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527842 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527835 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527828 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527811 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527804 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527798 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527781 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527774 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527767 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527750 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527736 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527491 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527514 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527521 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527583 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527590 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527606 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527682 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527699 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527705 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527712 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527729 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089527743 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 00190776402129 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
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| 07649988948701 | SPIRECUT | SPIRECUT SA | 2026-05-04 |
| 10886982198266 | NA | Synthes GmbH | 2016-12-31 |