Identity
- Trade Name
- SpinMedix® Absorbable Fibrous Membrane FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
- Model / Reference
- ZK-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975222391004 FDA UDI
- 510(k) Number
- K222220 FDA UDI
- FDA Product Code
- OWW FDA UDIFTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
SpinMedix® Absorbable Fibrous Membrane by Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable.
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Cleared under the same submission
K222220 also covers:
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
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
Sources (1)
- FDA UDI a290b220-11f3-4b55-8d2e-af42611c5c07 33 fields · synced May 30, 2026