Identity
- Trade Name
- PivoRod LP MIS Rod 5.5 x 65mm FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Model / Reference
- 16155-7065 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M739161557065 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
- 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
Category: Orthopaedic instrument surgical connector
PivoRod LP MIS Rod 5.5 x 65mm by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic instrument surgical connector.
- Surgical Instrument — Jeil Medical Corporation · Class I
- Maxim® Instrumentation — Biomet Orthopedics, Inc. · Class I
- QUANTUM — IN2BONES · Class I
- KINCISE™ System Acetabular Cup Extraction SST Head 28mm — Spierings Orthopaedics B.V. · Class I
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- Pilot Spinal System — Life Spine, Inc. · Class II
- Ti-Diagon — CAMBER SPINE TECHNOLOGIES · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Captiva Spine
Sources (1)
- FDA UDI 85085464-10f2-47f0-9c38-9d6f0e56948b 33 fields · synced Jun 6, 2026