Identity
- Trade Name
- Curved Rod, 5.5 x 160 FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- Curved Rod, 5.5 x 160 FDA UDI
- Model / Reference
- 2455-2160 FDA UDI
- Description
- Curved Rod, 5.5 x 160 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M73924552160 FDA UDI
- 510(k) Number
- K131538 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDI
- GMDN Term
- Orthopaedic instrument surgical connector 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
Curved Rod, 5.5 x 160 by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K131538 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, 5.5 x 50mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 7.5 x 40mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 7.5 x 95mm — Captiva Spine
- Curved Rod, 5.5 x 200 — Captiva Spine
- Curved Rod, 5.5 x 220 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 5.5 x 55 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 6.5 x 70 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 7.5 x 30 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 7.5 x 40 — 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 1c596ce7-d849-4eb7-b2a0-3f385443ebf0 35 fields · synced May 31, 2026