Identity
- Trade Name
- IsoTis Mozaik™ FDA UDI
- Generic Name
- Bone matrix implant, composite FDA UDI
- Device Name
- IsoTis Mozaik™ Putty, 5cc FDA UDI
- Model / Reference
- PTY10155ITL FDA UDI
- Description
- IsoTis Mozaik™ Putty, 5cc FDA UDI
Identifiers
- Catalog Number
- PTY10155ITL FDA UDI
- Primary DI / UDI-DI
- 10889981123277 FDA UDI
- 510(k) Number
- K062353 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, composite 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
Category: Bone matrix implant, composite
IsoTis Mozaik™ by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062353 also covers:
- OsteoStrux Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoStrux Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoStrux Putty — ISOTIS ORTHOBIOLOGICS, INC
- OsteoStrux Putty — ISOTIS ORTHOBIOLOGICS, INC
- Collage — Orthofix US LLC
- Collage — Orthofix US LLC
- Collage — Orthofix US LLC
- BoneSync — SeaSpine Orthopedics Corporation
- BoneSync — SeaSpine Orthopedics Corporation
- BoneSync — SeaSpine Orthopedics Corporation
- BoneSync — SeaSpine Orthopedics Corporation
- IsoTis Mozaik™ — SeaSpine Orthopedics Corporation
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 |
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Manufacturer
- Manufacturer
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI e502d2e0-d052-434a-852a-37ebbe3d37a9 38 fields · synced Jun 8, 2026