Identity
- Trade Name
- ALLY Bone Screw FDA UDI
- Generic Name
- Implantable cervical facet joint distractor FDA UDI
- Device Name
- The ALLY Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device. FDA UDI
- Model / Reference
- PD-32-301 FDA UDI
- Description
- The ALLY Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device. FDA UDI
Identifiers
- Catalog Number
- PD-32-301 FDA UDI
- Primary DI / UDI-DI
- 00852776006027 FDA UDI
- 510(k) Number
- K121713 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Implantable cervical facet joint distractor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Implantable cervical facet joint distractor
ALLY Bone Screw by Providence Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Providence Medical Technology, Inc.
Sources (1)
- FDA UDI c557da49-8eed-4f8d-ba02-41102e16f35b 35 fields · synced May 30, 2026