Identity
- Trade Name
- RESPONSE 5.5/6.0 SPINE SYSTEM FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 9.0mm, 110mm Length FDA UDI
- Model / Reference
- 00-1350-3911 FDA UDI
- Description
- 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 9.0mm, 110mm Length FDA UDI
Identifiers
- Catalog Number
- 00-1350-3911 FDA UDI
- Primary DI / UDI-DI
- 00841132182376 FDA UDI
- 510(k) Number
- K181390 FDA UDI
- FDA Product Code
- NKB FDA UDIKWP FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable 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
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: Spinal bone screw, non-bioabsorbable
Response 5.5/6.0 Spine System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
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 b5dd6f83-e537-44f5-a510-68138d3503e2 36 fields · synced May 30, 2026