← Back to catalogue
Synthacer
FDA UDIClass II (US FDA UDI)
by medArtis Medizinprodukte und Forschung Aktiengesellschaft
Identity
- Trade Name
- Synthacer FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Synthacer® 300 cylinder, HA, size 11, diameter 13.95 mm, length 25 mm, with lid FDA UDI
- Model / Reference
- T6111TMC-1 FDA UDI
- Description
- Synthacer® 300 cylinder, HA, size 11, diameter 13.95 mm, length 25 mm, with lid FDA UDI
Identifiers
- Catalog Number
- 6.111TMC FDA UDI
- Primary DI / UDI-DI
- 04250971400941 FDA UDI
- 510(k) Number
- K041177 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Pore Size — 300 Micrometer FDA UDIOuter Diameter — 13.95 Millimeter FDA UDILength — 25 Millimeter FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Synthacer by medArtis Medizinprodukte und Forschung Aktiengesellschaft — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone matrix implant, synthetic, non-antimicrobial.
- FIBERGRAFT BG Matrix — Prosidyan, Inc. · Class II
- MagnetOs — Kuros Biosciences B.V · Class II
- NovoGro Putty — OSTEONOVUS, INC. · Class II
- PRO OSTEON 500 — Biomet Orthopedics, Inc. · Class II
- NanoBone® SBX Putty — BIOCOMPOSITES LTD · Class II
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials · Class II
- Tribio® DP Cotton Wedge — Berkeley Advanced Biomaterials · Class II
- Porous Wedge - Cotton 5 mm — NovaBone Products, LLC · Class II
Cleared under the same submission
K041177 also covers:
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI 4528f2e4-1b89-4e7c-ad17-2d75dd768a6a 36 fields · synced Jun 8, 2026