Product code HXR
- Device name
- Spatula, 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 |
|---|---|---|---|
| K983882 | MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 | Micro-Medical Devices, Inc. | 1999-03-15 |
| K873387 | VIDEO ARTHROSCOPE, 1.7MM X 55 MM | Arthropedics, Inc. | 1987-11-25 |
| K872281 | RAYLOR FUSION FUNNEL | Cedar Surgical, Inc. | 1987-11-02 |
| K853436 | H-H HUNTER PASSIVE TENDON IMPLANT | Holter-Hausner Intl. | 1985-10-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09348811146717 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-20 |
| 09348811146700 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-20 |
| 04059223166280 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 14035282341254 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 14035282341247 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 14035282341223 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 14035282341278 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 14035282341230 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 14035282341216 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 04059223166273 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 04059223160844 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 04059223160837 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 04059223157943 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 04059223157899 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 04059223157875 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
| 14035282341261 | REMA Shaver Blades | DEWIMED Medizintechnik GmbH | 2025-02-26 |
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| 00842517117280 | Karl Schumacher | Karl Schumacher Dental, LLC | 2024-03-15 |
| 00850047707260 | Gill | The Radebaugh-Fetzer Company | 2023-06-01 |
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| 10381780436645 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-06-15 |
| 03663136027616 | NA | SPINEVISION | 2016-02-03 |
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