Identity
- Trade Name
- Fastener Sleeve with Handle FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Device Name
- Fastener Sleeve with Handle FDA UDI
- Model / Reference
- 2004-0001-01 FDA UDI
- Description
- Fastener Sleeve with Handle FDA UDI
Identifiers
- Catalog Number
- 2004-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00816950027819 FDA UDI
- 510(k) Number
- K170021 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: General external orthopaedic fixation system implantation kit, reusable
Fastener Sleeve with Handle by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General external orthopaedic fixation system implantation kit, reusable.
- GPC — Gpc Medical, Ltd. · Class I
- GPC — Gpc Medical, Ltd. · Class I
- GPC — Gpc Medical, Ltd. · Class I
- GPC — Gpc Medical, Ltd. · Class I
- Zavation SCREW TO SCREW COMPRESSOR — ZAVATION · Class II
- GPC — Gpc Medical, Ltd. · Class I
- Cross Element Guide Sleeve — TOBY ORTHOPAEDICS · Class I
- GPC — Gpc Medical, Ltd. · Class I
Cleared under the same submission
K170021 also covers:
- 1.6mm Guide Wire Smooth Trocar 150mm — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver Cann Fixed — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver, AO QC Shaft 290mm — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver, Fixed 290mm — OsteoCentric Technologies,Inc
- 2.74mm Guidewire, Threaded Trocar Tip SS, 450mm — OsteoCentric Technologies,Inc
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc
- 2.8 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc
- 2.8/3.5mm Double Drill Guide — OsteoCentric Technologies,Inc
- 4.0 X 105mm CANN SCREW FASTENER Ti SH THD — OsteoCentric Technologies,Inc
- 4.0 X 110mm CANN SCREW FASTENER Ti SH THD — OsteoCentric Technologies,Inc
- 4.0 X 115mm CANN SCREW FASTENER Ti FL THD — OsteoCentric Technologies,Inc
- 4.0 X 115mm CANN SCREW FASTENER Ti LG THD — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 17fb76d8-c56e-4918-9647-b12c0cdd9703 36 fields · synced Jun 1, 2026