MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA
Newnan, GA, US
MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA appears in FDA device records in Newnan, GA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Matrix Surgical Holdings, LLCenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009383407 | 3009383407 | MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA | 98 Bledsoe Road, Newnan, GA 30265 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1224-2019 | OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton. | Product mislabeling. | Class II | Terminated | |
| Z-1223-2019 | 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 surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton. | Product mislabeling. | Class II | Terminated | |
| Z-1382-2017 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain