Product code HXK
- Device name
- Holder, Needle; Orthopedic
- 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 |
|---|---|---|---|
| K890167 | HOLDER, NEEDLE | Dhason Brothers, Inc. | 1989-02-03 |
| K872989 | MICRINS NEEDLE HOLDER | Micrins Surgical, Inc. | 1987-08-21 |
| K860018 | FISCHER WIRE/PIN CLAMP | Buckman Co., Inc. | 1986-02-07 |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | Ace Orthopedic Manufacturing Co. | 1980-09-09 |
| K772388 | CONVERSE-GILLIES NEEDLE HOLDER | Edward Weck, Inc. | 1978-01-20 |
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|---|---|---|---|
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| 00190776435097 | Millennium | Avalign Technologies, Inc. | 2026-10-15 |
| 04058749027969 | NA | Fehling Instruments GmbH & Co. KG | 2026-10-12 |
| 00840217910484 | Ace Medical Company | EBNER MEDICAL, LLC | 2026-08-13 |
| 00840217910477 | Ace Medical Company | EBNER MEDICAL, LLC | 2026-08-13 |
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| 00840217910453 | Ace Medical Company | EBNER MEDICAL, LLC | 2026-08-13 |
| 00840217910446 | Ace Medical Company | EBNER MEDICAL, LLC | 2026-08-13 |
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| 00850083275235 | Intrace USA | PILOTIS TECH LLC | 2026-07-03 |
| 00840217910163 | Wiggins medical | EBNER MEDICAL, LLC | 2025-12-10 |
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| 00840217903431 | ACE Medical Company | EBNER MEDICAL, LLC | 2021-06-09 |
| 00888118025722 | NEEDLE HOLDER | KLS-Martin L.P. | 2018-09-26 |