Data / Medical devices / United States / MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA
MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA: FDA-registered device maker in Newnan, GA, United States, 3 510(k) clearances
MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA is registered with the FDA (registration 3009383407) in Newnan, GA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 11, 2018. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009383407
- Address
- 98 Bledsoe Road, Newnan, GA, United States, 30265
- Owner or operator
- Matrix Surgical Holdings, LLC. dba Matrix Surgical USA (10038239)
- Roles
- Manufacturer
- First device listed
- August 6, 2013
- Registered through
- 2026
- Brand names listed
- HTR-OMNIPORE Patient Matched Implant, OMNIPORE DUROMAX Surgical Implants, OMNIPORE DUROMAX ZB Orbital Implant, OMNIPORE(R) Surgical Implant, OmniPore Customized Surgical Implant, Seiff Ptosis Sling
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crutch, Ptosis | HJZ | 1 | Manufacturer | accessdata.fda.gov |
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 11, 2018 | K180249 | OmniPore DUROMAX Surgical Implants | JEY | Substantially Equivalent | Matrix Surgical Holdings, LLC/Matrix Surgical USA | accessdata.fda.gov |
| May 14, 2014 | K133046 | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS | KKY | Substantially Equivalent | Matrix Surgical Holdings, LLC/Matrix Surgical USA | accessdata.fda.gov |
| July 31, 2013 | K123908 | OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES | KKY | Substantially Equivalent | Matrix Surgical USA | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 30, 2019 | 82487 | Class II | Terminated | OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic | Product mislabeling. | accessdata.fda.gov |
| January 25, 2017 | 76356 | Class II | Terminated | OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right | Mislabeling. The packaging labeled as left mandible contained a right mandible. | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Bone
- All makers of Crutch, Ptosis
- All makers of Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Updated October 11, 2018. 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.