Identity
- Trade Name
- IO-FLEX FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- IO-Flex MicroBlade Shaver 10mm w/ side cutter FDA UDI
- Model / Reference
- iO-MBS10sc FDA UDI
- Description
- IO-Flex MicroBlade Shaver 10mm w/ side cutter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840916103842 FDA UDI
- 510(k) Number
- K113533 FDA UDI
- FDA Product Code
- HAE FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
Io-Flex by Spinal Elements, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
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- MyKnee — Medacta International · Class II
- MyKnee PPS — Medacta International · Class II
- MyKnee — Medacta International · Class II
- MyKnee — Medacta International · Class II
- My Knee Tibial Cutting Blocks MIS — Medacta International · Class II
- My Spine Low Profile Placement Guides — Medacta International · Class II
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Cleared under the same submission
K113533 also covers:
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
- IO-FLEX — SPINAL ELEMENTS, INC.
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
- Spinal Elements, Inc.
Sources (1)
- FDA UDI 8720ff08-2d54-4933-ac22-00a4a0937bfb 34 fields · synced Jun 1, 2026