Identity
- Trade Name
- Inion OTPS™ FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- Mesh plate, 14x14 holes FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Mesh plate, 14x14 holes FDA UDI
Identifiers
- Catalog Number
- MSH-1035 FDA UDI
- Primary DI / UDI-DI
- M224MSH10359 FDA UDI
- 510(k) Number
- K031961 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Inion OTPS™ by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable.
- PDS Plates — Ethicon Inc. · Class II
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- GalaFLEX 3D — Tepha, Inc. · Class II
- TIGR® Matrix Surgical Mesh — Novus Scientific AB · Class II
- Phasix — Davol Inc. · Class II
- GalaFLEX LITE — Tepha, Inc. · Class II
Cleared under the same submission
K031961 also covers:
- Inion OTPS™ — Inion , Ltd.
- Inion OTPS™ — Inion , Ltd.
- Inion OTPS™ — Inion , Ltd.
- Inion OTPS™ Biodegradable Screw — Inion , Ltd.
- Inion OTPS™ Biodegradable Screw — Inion , Ltd.
- Inion OTPS™ Biodegradable Screw — Inion , Ltd.
- Inion OTPS™ Biodegradable Screw — Inion , Ltd.
- Inion OTPS™ Biodegradable Screw — Inion , Ltd.
- Inion OTPS™ Biodegradable Screw — Inion , 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
- Manufacturer
- Inion , Ltd.
Sources (1)
- FDA UDI 7335281e-d27e-43c6-b833-0fa96d92d049 36 fields · synced Jun 6, 2026