Awl
An awl is a pointed handheld orthopedic surgical instrument used to perforate or pierce bone in order to create a starting hole for screws, pins, or intramedullary devices. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HWJ falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HWJ
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K895587 | CROSS MEDICAL PRODUCT PEDICLE AWL | Jan 04, 1990 | Substantially Equivalent | Cross Medical Products, Inc. |
| K880045 | ACROMED AWL/PUNCH, DEPTH GAUGE | Feb 17, 1988 | Substantially Equivalent | Buckman Co., Inc. |
| K875223 | DANNINGER ORTHOPAEDIC AWL | Feb 17, 1988 | Substantially Equivalent | Danninger Medical Technology, Inc. |
| K870779 | ACROMED WALLIE-HEINIG TROCHAR | Mar 09, 1987 | Substantially Equivalent | Buckman Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 325 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 325 registration numbers. Click on an entry to view related FDA registrations.