Product code HXZ
- Device name
- Cutter, Wire
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- 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 |
|---|---|---|---|
| K873715 | BONE PIN CUTTER 18 | Military Engineering, Inc. | 1987-10-28 |
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| B8034606210 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| B8034606250 | ORTHOMED | ORTHO-MED, INC. | 2026-07-14 |
| 00810207784005 | Van Sickle | VAN SICKLE SURGICAL INSTRUMENTS, INCORPORATED | 2026-07-07 |
| 00810207784012 | Van Sickle | VAN SICKLE SURGICAL INSTRUMENTS, INCORPORATED | 2026-07-07 |
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| 08800089423880 | Surgical Instrument | Jeil Medical Corporation | 2026-04-09 |
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| 07898506853656 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 07898506853687 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 07898506853694 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| EZPF31760210 | HELMUT ZEPF | Helmut Zepf Medizintechnik GmbH | 2022-12-16 |
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| 08809282812095 | Mesh Punch | Jeil Medical Corporation | 2018-09-07 |
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| J011014151000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011004266000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
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| J011003702000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011003701000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011003700000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |