Screw Sleeve Bone Fixation Device
QAC is the FDA product code for Screw Sleeve Bone Fixation Device, a class II device type, regulated under 21 CFR 888.3043. FDA's definition for this code reads: "A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QAC
- Device name
- Screw Sleeve Bone Fixation Device
- FDA definition
- A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.
- Regulation
- 21 CFR 888.3043
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QAC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2020 | 1 |
Applicants with the most clearances
Product code QAC| Applicant | Clearances |
|---|---|
| woven Orthopedic Technologies | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QAC.
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