Identity
- Trade Name
- Response Rib and Pelvic System FDA UDI
- Generic Name
- Vertical expandable prosthetic rib system FDA UDI
- Device Name
- PELVIC LOCKING SCREW, 35.0 FDA UDI
- Model / Reference
- 00-1600-4350 FDA UDI
- Description
- PELVIC LOCKING SCREW, 35.0 FDA UDI
Identifiers
- Catalog Number
- 00-1600-4350 FDA UDI
- Primary DI / UDI-DI
- 00840194428347 FDA UDI
- 510(k) Number
- K233105 FDA UDI
- FDA Product Code
- MDI FDA UDI
- GMDN Term
- Vertical expandable prosthetic rib system 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
Yes
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
MR Conditional FDA UDI
Category: Vertical expandable prosthetic rib system
Response Rib and Pelvic System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vertical expandable prosthetic rib system.
- Response 4.5/5.0 Spine System — ORTHOPEDIATRICS CORP. · Class I
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP. · Class II
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP. · Class II
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP. · Class II
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP. · Class II
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP. · Class II
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP. · Class II
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP. · Class II
Cleared under the same submission
K233105 also covers:
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
- Response Rib and Pelvic System — ORTHOPEDIATRICS CORP.
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
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 98bd001e-2a35-4374-9f34-ececb26edbd7 35 fields · synced May 30, 2026