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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