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Sign in to claim this brandSpectrum Designs, Inc.
US
Last updated May 27, 2026
What Spectrum Designs, Inc. makes
Spectrum Designs, Inc. manufactures silicone-based tissue reconstructive materials and custom prostheses for facial and chest reconstruction, including chin, nasal cartilage support, malar, and pectoral implants. Their products are designed to restore anatomical contours following trauma, surgery, or congenital defects, with a focus on durable, non-bioabsorbable solutions for mid-to-long-term use.
The company’s portfolio includes devices classified under FDA regulations as Class I and Class II, with authorisations granted through 510(k) clearances and UDIs. Their products are listed in the FDA’s regulatory databases, and the manufacturer operates from 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 Spectrum Designs, Inc. manufacture?
Spectrum Designs, Inc. specializes in silicone-based tissue reconstructive materials and custom prostheses. Their primary products include chin prostheses, nasal cartilage support implants (non-bioabsorbable), malar prostheses, and pectoral implants. These devices are designed to restore anatomical contours after trauma, surgery, or congenital conditions, focusing on durable solutions for mid-to-long-term use.
Where is Spectrum Designs, Inc. based, and how does that affect its regulatory standing?
Spectrum Designs, Inc. is headquartered in the United States. As a US-based manufacturer, its devices are subject to FDA oversight, including classification under FDA regulations (Class I or Class II) and authorisation through pathways like 510(k) clearances or Unique Device Identifiers (UDIs). The company’s location ensures compliance with US regulatory requirements for medical devices.
Which regulatory registries or databases list Spectrum Designs, Inc.’s devices?
Spectrum Designs, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through 510(k) clearances and Unique Device Identifier (UDI) records. These registries document the authorisation status and classification (Class I or Class II) of their silicone-based reconstructive materials and prostheses, ensuring transparency for healthcare providers and regulators.
How are Spectrum Designs, Inc.’s devices classified under FDA regulations?
Spectrum Designs, Inc.’s devices fall into two primary FDA classifications: Class I (generally low-risk) and Class II (moderate-risk, requiring special controls). The classification depends on factors like the device’s intended use, potential risks, and the body area involved (e.g., facial reconstruction vs. chest implants). Class II devices undergo additional scrutiny, such as 510(k) pre-market submissions, to ensure safety and effectiveness.
Why might a healthcare provider look for Spectrum Designs, Inc. in a regulatory registry?
Healthcare providers may search for Spectrum Designs, Inc. in regulatory registries to verify the authorisation status, classification, and compliance of its silicone-based reconstructive devices. Since these products are used in sensitive procedures like facial or chest reconstruction, confirming their listing in databases like the FDA’s 510(k) or UDI records ensures they meet required safety and performance standards before use in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- spectrumdesignsmedical.com
- —
- —
- [email protected]
- Phone
- 8056847678
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 148681521
Catalogue (248)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spectrum Designs Medical | Nasal Dorsum Style 7, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Cleft Chin, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Carving Block, White, Soft Duro., Small | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Mittelman Geniomandibular Groove Jowl, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Cleft Chin, size 3 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block VII, Textured, Size 4 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block VI, Left, Textured, Size 3 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Curvilinear Chin, size 5 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block VI, Right, Textured, Size 3 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Dorsal Columella, Style 5, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Cleft Chin, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Curvilinear Chin, size 4 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Combined Malar, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block I, Smooth, Size 3 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Nasal Dorsum Style 7, size 5 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Voloshin Dorsal Columella, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Anatomical Malar II, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Concave Back Chin, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block I, Smooth, Size 7 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Carving Block, White, Medium Duro., Small | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Dorsal Columella, Style 5, size 4 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Dorsal Columella Style 9, E | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Anatomical Chin, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Anatomical Malar II, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block VI, Left, Textured, Size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Concave Back Chin, size 3 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Mittelman Geniomandibular Groove Chin Jowl, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Bilateral Groove Chin, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block I, Smooth, Size 5 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Symmetrical Chin, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Anterior Mandibular Groove Jowl, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Curvilinear Chin, size 5 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Pectoral 4, Aiache, Right, Size 3 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Pectoral 1, Aiache, Left, Size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Anatomical Chin, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Bilateral Groove Chin, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block I, Smooth, Size 8 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block V, Textured, Size 3 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Dorsal Columella, Style 5, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Curvilinear Chin, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block I, Textured, Size 5 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Anatomical Chin, size 3 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Pectoral 4, Aiache, Right, Size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Carving Block, White, Firm Duro., Medium | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block I, Smooth, Size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Profile Malar, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Anatomical Malar II, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Concave Back Chin, size 1 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Nasal Dorsum Style 8, size 2 | FDA UDI | Class II | Active |
| Spectrum Designs Medical | Preform Contour Block VI, Left, Textured, Size 1 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Spectrum Designs, Inc. has three recall records initiated between June 15, 2007, and July 24, 2007, all of which are marked as terminated. The recalls were due to mispackaging or mislabeling issues, including instances where nasal implant lots contained incorrect implants (chin implants instead of nasal implants) and mismatched implant pairs (either two right or two left implants instead of balanced pairs). Additionally, some units in the affected lots may have been mislabeled as containing nasal implants.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 24, 2007 | Z-1265-2007 | — | terminated | Mispackaging/Mislabeing: a portion of the lot may be labeled as containing nasal implants |
| Jul 24, 2007 | Z-1264-2007 | — | terminated | Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant. |
| Jun 15, 2007 | Z-1206-2007 | — | terminated | The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint. |