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Response Navigation
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 01-1800-1040Model 01-1800-1030
Identity
- Trade Name
- ORTHOPEDIATRICS® INSTRUMENTATION EUDAMEDResponse Navigation FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- ORTHOPEDIATRICS® INSTRUMENTATION EUDAMED4.0mm Tap, Navigation FDA UDI
- Model / Reference
- 01-1800-1040 EUDAMEDFDA UDI01-1800-1030 EUDAMED
- Description
- 4.0mm Tap, Navigation FDA UDI
Identifiers
- Catalog Number
- 01-1800-1040 FDA UDI
- Primary DI / UDI-DI
- 00841132135693 EUDAMEDFDA UDI
- Basic UDI-DI
- 08411321CIIATAP6K EUDAMED
- 510(k) Number
- K203573 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Bone tap, reusable
Response Navigation by Orthopediatrics Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reusable.
- BIOSURE — Smith & Nephew, Inc. · Class I
- NobelActive® — Nobel Biocare AG · Class I
- CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
- PressON™ — NEXUS SPINE, L.L.C. · Class I
- Insite — TORNIER, INC. · Class I
- ReLine — Nuvasive, Inc. · Class I
- Mariner MIS — SeaSpine Orthopedics Corporation · Class I
- Nautilus Spinal System — Life Spine, Inc. · Class II
Cleared under the same submission
K203573 also covers:
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (2)
- FDA UDI 9efe4e62-0185-42fe-bed2-99ecf37f56a3 36 fields · synced Jul 30, 2026
- EUDAMED c4d8868f-ff00-47ab-81f5-185972b34ba8 61 fields · synced Jul 30, 2026