Identity
- Trade Name
- iNSitu™ Hip System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- Acetabular Bone Screw, 6.5mm x 20mm FDA UDI
- Model / Reference
- 10-60-6520 FDA UDI
- Description
- Acetabular Bone Screw, 6.5mm x 20mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816127023040 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDIOQG FDA UDIOQI FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, sterile
iNSitu™ Hip System by Nextstep Arthropedix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.
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- Cortical Screw 2.5mm x 24mm Sterile — BIOPRO, INC. · Class II
- OsteoMed — Osteomed Corp. · Class II
- 3.5mm x 10mm Ti Cortical Screw — WISHBONE MEDICAL INC. · Class II
- primaLOK FF — Wenzel Spine · U
- MAX VPC™VARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, Inc. · Class II
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
- Nextstep Arthropedix
Sources (1)
- FDA UDI ac1f5ff8-42f2-4568-9220-cbe85ab4dc6b 34 fields · synced Jun 8, 2026