Identity
- Trade Name
- RESPONSE Spine FDA UDI
- Generic Name
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- 5.5MM ROD, COCR, SINGLE HEX, 500MM LENGTH FDA UDI
- Model / Reference
- 00-1003-5553 FDA UDI
- Description
- 5.5MM ROD, COCR, SINGLE HEX, 500MM LENGTH FDA UDI
Identifiers
- Catalog Number
- 00-1003-5553 FDA UDI
- Primary DI / UDI-DI
- 00841132136461 FDA UDI
- 510(k) Number
- K160466 FDA UDI
- FDA Product Code
- KWP FDA UDIOSH FDA UDI
- GMDN Term
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- Not 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
RESPONSE Spine by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 01372cf9-b771-4937-91b6-d5f35fc1ceff 37 fields · synced Jun 1, 2026