Identity
- Trade Name
- Polyaxial Reduction Screw, 7.5 x 85 FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- Polyaxial Reduction Screw, 7.5 x 85 FDA UDI
- Model / Reference
- 2416-7585 FDA UDI
- Description
- Polyaxial Reduction Screw, 7.5 x 85 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M73924167585 FDA UDI
- 510(k) Number
- K122332 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- Not 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
Polyaxial Reduction Screw, 7.5 x 85 by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K122332 also covers:
- Articulating Perc Rod, 5.5 x 35mm — Captiva Spine
- Articulating Perc Rod, 5.5 x 45mm — Captiva Spine
- Articulating Perc Rod, 5.5 x 50mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 6.5 x 75mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 7.5 x 95mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 8.0 x 65mm — Captiva Spine
- MIS Cannulated Polyaxial Screw, 5.5 x 30 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 5.5 x 55 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 6.5 x 40 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 6.5 x 45 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 6.5 x 65 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 6.5 x 70 — Captiva Spine
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
- Captiva Spine
Sources (1)
- FDA UDI 0b298677-eb3c-4336-aa31-c981619058ee 35 fields · synced Jun 8, 2026