Identity
- Trade Name
- BladeX Blade Sterile FDA UDI
- Generic Name
- Orthopaedic osteotome blade, single-use FDA UDI
- Device Name
- BladeX Blade Sterile FDA UDI
- Model / Reference
- 202-82038-S FDA UDI
- Description
- BladeX Blade Sterile FDA UDI
Identifiers
- Catalog Number
- 202-82038-S FDA UDI
- Primary DI / UDI-DI
- 00810097801196 FDA UDI
- 510(k) Number
- K161755 FDA UDI
- FDA Product Code
- GES FDA UDI
- GMDN Term
- Orthopaedic osteotome blade, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 38 Millimeter FDA UDI
Category: Orthopaedic osteotome blade, single-use
BladeX Blade Sterile by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic osteotome blade, single-use.
- KINCISE™ System Acetabular Cup Extraction Finisher Blade 52mm — Spierings Orthopaedics B.V. · Class I
- RP Medical — Rp Medical, Inc. · Class I
- KINCISE™ System Acetabular Cup Extraction Finisher Blade 44mm — Spierings Orthopaedics B.V. · Class I
- IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD. · Class I
- IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- RP Medical — Rp Medical, Inc. · Class I
- IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD. · Class I
Cleared under the same submission
K161755 also covers:
- 10 x 100mm SI Fusion Fastener Cann Sterile — OsteoCentric Technologies,Inc
- 10 x 105mm SI Fusion Fastener Cann Sterile — OsteoCentric Technologies,Inc
- 10 x 110mm SI Fusion Fastener Cann Sterile — OsteoCentric Technologies,Inc
- 10 x 40mm SI Fusion Fastener Cann Sterile — OsteoCentric Technologies,Inc
- 10 x 50mm Anodized SI Implant — OsteoCentric Technologies,Inc
- 10 x 50mm SI Fusion Fastener Cann Sterile — OsteoCentric Technologies,Inc
- 10 x 55mm Anodized SI Implant — OsteoCentric Technologies,Inc
- 10 x 55mm SI Fusion Fastener Cann Sterile — OsteoCentric Technologies,Inc
- 10 x 60mm Anodized SI Implant — OsteoCentric Technologies,Inc
- 10 x 60mm SI Fusion Fastener Cann Sterile — OsteoCentric Technologies,Inc
- 10 x 65mm Anodized SI Implant — OsteoCentric Technologies,Inc
- 10 x 65mm SI Fusion Fastener Cann Sterile — OsteoCentric Technologies,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 I | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 1e22b9d0-7b82-4057-bb3c-eb31c320ab1d 37 fields · synced May 30, 2026