Identity
- Trade Name
- Polyaxial Reduction Screw, 7.5 x 55 FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- Polyaxial Reduction Screw, 7.5 x 55 FDA UDI
- Model / Reference
- 2416-7555 FDA UDI
- Description
- Polyaxial Reduction Screw, 7.5 x 55 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M73924167555 FDA UDI
- 510(k) Number
- K120292 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI 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 55 by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K120292 also covers:
- Cannulated Polyaxial Reduction Screw, 4.9 x 40mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 5.5 x 50mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 7.5 x 30mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 7.5 x 40mm — Captiva Spine
- Curved Rod, 5.5 x 100 — Captiva Spine
- Curved Rod, 5.5 x 130 mm — Captiva Spine
- Curved Rod, 5.5 x 190 mm — Captiva Spine
- Curved Rod, 5.5 x 90 — Captiva Spine
- POLYAXIAL SCREW, 5.5 x 45 — Captiva Spine
- Polyaxial Reduction Screw, 5.5 x 50 — Captiva Spine
- Polyaxial Reduction Screw, 6.5 x 30 — Captiva Spine
- Polyaxial Reduction Screw, 6.5 x 35 — 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 32937c88-6264-42d2-b088-ca27cf1afb48 35 fields · synced Jun 8, 2026