Data / Medical devices / Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use (PBQ): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Fixation, Non-Absorbable Or Absorbable, For Pelvic Use (product code PBQ, Class 2, 21 CFR 884.4530). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on March 4, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PBQ
- Device class
- 2
- Regulation
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Israel | 3 |
| United States | 2 |
| Spain | 1 |
Makers of Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coloplast Manufacturing Us, LLC | Minneapolis, MN, United States | Specification developer | 1 | June 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Desarrollo E Investigacion Medica Aragonesa SL | CALATAYUD Zaragoza, Spain | Manufacturer | 1 | October 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| Escala Medical | Business Park Misgav Northern, Israel | Manufacturer | 1 | July 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| FEMSelect Ltd | Modi'in Central, Israel | Manufacturer | 1 | July 6, 2016 | 0 | 1 | 0 | api.fda.gov |
| Aprios Custom Mfg. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resonetics, LLC | Or Akiva Central, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.