Holder, Needle; Orthopedic
An orthopedic needle holder is a ratcheted, handheld instrument designed to grasp and manipulate curved suture needles during orthopedic repair procedures requiring suture placement. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HXK falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HXK
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890167 | HOLDER, NEEDLE | Feb 03, 1989 | Substantially Equivalent | Dhason Brothers, Inc. |
| K872989 | MICRINS NEEDLE HOLDER | Aug 21, 1987 | Substantially Equivalent | Micrins Surgical, Inc. |
| K860018 | FISCHER WIRE/PIN CLAMP | Feb 07, 1986 | Substantially Equivalent | Buckman Co., Inc. |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | Sep 09, 1980 | Substantially Equivalent | Ace Orthopedic Manufacturing Co. |
| K772388 | CONVERSE-GILLIES NEEDLE HOLDER | Jan 20, 1978 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 241 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 241 registration numbers. Click on an entry to view related FDA registrations.