Product code GFI
- Device name
- Osteotome, Manual
- 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 |
|---|---|---|---|
| K933181 | VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 | Valleylab, Inc. | 1993-11-02 |
| K932534 | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS | Innovative Surgical, Inc. | 1993-08-19 |
| K920001 | HEMOLAB SILIMAT REAGENT | Biomerieux Vitek, Inc. | 1992-09-25 |
| K891887 | OSTEOTOMES, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K852541 | STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS | Storz Instrument Co. | 1985-07-11 |
| K842823 | CHERMEL OSTEOTOMES | Cher Mel Corp. | 1984-08-02 |
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| 10381780188162 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780188155 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
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| 10381780125969 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-12 |
| 10381780125952 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-12 |