Identity
- Trade Name
- Response 5.5/6.0 Spine System FDA UDI
- Generic Name
- Orthopaedic rod reducer FDA UDI
- Device Name
- JIMINY ROD REDUCER FDA UDI
- Model / Reference
- 01-1003-5000 FDA UDI
- Description
- JIMINY ROD REDUCER FDA UDI
Identifiers
- Catalog Number
- 01-1003-5000 FDA UDI
- Primary DI / UDI-DI
- 00841132122501 FDA UDI
- 510(k) Number
- K181390 FDA UDI
- FDA Product Code
- NKB FDA UDIKWP FDA UDI
- GMDN Term
- Orthopaedic rod reducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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 rod reducer
Response 5.5/6.0 Spine System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic rod reducer.
- MONUMENT — GLOBUS MEDICAL, INC. · Class I
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- Mariner MCT — SeaSpine Orthopedics Corporation · Class I
- PERLA ® — Spineart · Class II
- Prodigy Pedicle Screw System — Curiteva, LLC · Class II
- PERLA ® — Spineart · Class II
- ReLine — Nuvasive, Inc. · Class I
Cleared under the same submission
K181390 also covers:
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE SYSTEM — ORTHOPEDIATRICS CORP.
- RESPONSE 5.5/6.0 SPINE 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 e57472bf-acbd-4c89-88fc-78e4b29a7cf6 36 fields · synced May 30, 2026