Identity
- Trade Name
- Solstice Occipito-Cervico-Thoracic System FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- 50mm-65mm DS Straight Cross Connector FDA UDI
- Model / Reference
- 902-5065 FDA UDI
- Description
- 50mm-65mm DS Straight Cross Connector FDA UDI
Identifiers
- Catalog Number
- 902-5065 FDA UDI
- Primary DI / UDI-DI
- 00190837063412 FDA UDI
- 510(k) Number
- K150229 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Orthopaedic instrument surgical connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 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
Solstice Occipito-Cervico-Thoracic System by Life Spine, Inc. — 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
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- QUANTUM — IN2BONES · Class I
- KINCISE™ System Acetabular Cup Extraction SST Head 28mm — Spierings Orthopaedics B.V. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · Class II
- Ti-Diagon — CAMBER SPINE TECHNOLOGIES · Class I
- Dr.Paleys Osteotomy System — Orthopediatrics Canada ULC · Class I
Cleared under the same submission
K150229 also covers:
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
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
- Life Spine, Inc.
Sources (1)
- FDA UDI 7e8fd913-c0c5-4ed4-ae68-93880a1c58e9 35 fields · synced May 31, 2026