Identity
- Trade Name
- geneX® putty FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. FDA UDI
- Model / Reference
- 920-002 FDA UDI
- Description
- geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. FDA UDI
Identifiers
- Catalog Number
- 920-002 FDA UDI
- Primary DI / UDI-DI
- 50601557101674 FDA UDI
- 510(k) Number
- K073341 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- Not 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
geneX® putty by Biocomposites Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K073341 also covers:
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
- Manufacturer
- Biocomposites Ltd
Sources (1)
- FDA UDI 6f139929-0996-47d6-8f3b-c1e24554fe1c 39 fields · synced May 30, 2026