Identity
- Trade Name
- PivoRod LP MIS Rod 5.5 x 40mm FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Model / Reference
- 16155-7040 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M739161557040 FDA UDI
- 510(k) Number
- K151116 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH 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
PivoRod LP MIS Rod 5.5 x 40mm by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K151116 also covers:
- Cross Connector, Medium-Large — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 100mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 110mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 120mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 140mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 160mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 180mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 200mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 220mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 240mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 35mm — Captiva Spine
- PivoRod LP MIS Rod 5.5 x 40mm — 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 29451ca7-5280-4e13-8095-bc85680235f8 34 fields · synced May 29, 2026