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Sign in to claim this brandOssdsign AB
US
Last updated May 25, 2026
What Ossdsign AB makes
Ossdsign AB manufactures synthetic, non-antimicrobial bone matrix implants and cranial reconstruction devices. Their portfolio includes bone void fillers like the OssDsign Catalyst, cranial defect plugs such as the OSSDSIGN Cranioplug and OSSDSIGN Cranial PSI, and anatomical accessories for surgical planning and trial fitting.
These products are classified as Class II medical devices under FDA regulations and are recorded in the FDA’s 510(k) and UDI databases. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Ossdsign AB manufacture?
Ossdsign AB specializes in synthetic, non-antimicrobial bone matrix implants. Their primary focus is on products designed for bone reconstruction and cranial defect repair, including bone void fillers like the OssDsign Catalyst and cranial reconstruction devices such as the OSSDSIGN Cranioplug and OSSDSIGN Cranial PSI. These devices are intended to support bone healing and structural integrity in surgical applications.
Where is Ossdsign AB based?
Ossdsign AB is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for markets regulated by U.S. authorities like the FDA.
Which regulatory registries list Ossdsign AB’s devices?
Ossdsign AB’s devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations, allowing healthcare providers and regulators to verify device details and authorization status.
How are Ossdsign AB’s devices classified under FDA regulations?
Ossdsign AB’s devices fall under Class II classification according to FDA regulations. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. The company’s bone matrix implants and cranial reconstruction devices meet these criteria due to their intended use in surgical applications where precision and biocompatibility are critical.
What is the purpose of Ossdsign AB’s anatomical accessories, like the Cranial PSI Accessory models?
The anatomical accessories, such as the Cranial PSI Accessory models (e.g., anatomical models and trial implants), are designed to aid surgeons in preoperative planning and intraoperative fitting. These tools help visualize and test cranial defect reconstructions before final implantation, improving surgical precision and patient outcomes by allowing clinicians to assess fit, alignment, and customization prior to using the actual implant.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 350354370
Catalogue (38)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OSSDSIGN Cranioplug | 14 mm, 6 fixation-points | FDA UDI | Class II | Unknown |
| Plastic Drawing Guide | L | FDA UDI | Class II | Unknown |
| Anatomical Model Modified | M | FDA UDI | Class II | Unknown |
| Cranial Implant Trial | XL | FDA UDI | Class II | Unknown |
| Cranial Implant Trial | S | FDA UDI | Class II | Unknown |
| Anatomical Model Original | Whole skull | FDA UDI | Class II | Unknown |
| OSSDSIGN Cranioplug | 11 mm, 6 fixation-points | FDA UDI | Class II | Unknown |
| Cranial Implant Trial | M | FDA UDI | Class II | Unknown |
| OSSDSIGN Cranial PSI | L | FDA UDI | Class II | Unknown |
| OSSDSIGN Cranial PSI | M | FDA UDI | Class II | Unknown |
| OSSDSIGN Cranioplug | 11 mm, 2 fixation-points | FDA UDI | Class II | Unknown |
| Plastic Drawing Guide | S | FDA UDI | Class II | Unknown |
| OSSDSIGN Cranioplug | 14 mm, 2 fixation-points | FDA UDI | Class II | Unknown |
| OssDsign Catalyst | 1 cc | FDA UDI | Class II | Active |
| Anatomical Model Original | M | FDA UDI | Class II | Unknown |
| OssDsign Catalyst | 10cc | FDA UDI | Class II | Active |
| Anatomical Model Modified | L | FDA UDI | Class II | Unknown |
| OssDsign Catalyst | 5cc | FDA UDI | Class II | Active |
| OSSDSIGN Cranial PSI | XL | FDA UDI | Class II | Unknown |
| Anatomical Model Original | L | FDA UDI | Class II | Unknown |
| Plastic Drawing Guide | XL | FDA UDI | Class II | Unknown |
| Anatomical Model Original | XL | FDA UDI | Class II | Unknown |
| OssDsign Catalyst | 2.5cc | FDA UDI | Class II | Active |
| Anatomical Model Modified | Half skull | FDA UDI | Class II | Unknown |
| Plastic Drawing Guide | M | FDA UDI | Class II | Unknown |
| Anatomical Model Original | S | FDA UDI | Class II | Unknown |
| Anatomical Model Modified | XL | FDA UDI | Class II | Unknown |
| Anatomical Model Modified | S | FDA UDI | Class II | Unknown |
| OSSDSIGN Cranial PSI | S | FDA UDI | Class II | Unknown |
| Anatomical Model Modified | Whole skull | FDA UDI | Class II | Unknown |
| Cranial Implant Trial | L | FDA UDI | Class II | Unknown |
| Anatomical Model Original | Half skull | FDA UDI | Class II | Unknown |
| OSSDSIGN Cranioplug | K181539 | FDA 510(k) | Class II | Active |
| Cranioplug | K140309 | FDA 510(k) | Class II | Active |
| Cranial PSI | K161090 | FDA 510(k) | Class II | Active |
| Catalyst Bone Void Filler | K232315 | FDA 510(k) | Class II | Active |
| Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial | K190523 | FDA 510(k) | Class II | Active |
| OSSDSIGN Cranial PSI | K212414 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Ossdsign Uppsala · SE FEI 3013282271