Identity
- Trade Name
- Disposable Impactor FDA UDI
- Generic Name
- Implantable cervical facet joint distractor FDA UDI
- Model / Reference
- SR19-3000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850040139792 FDA UDI
- 510(k) Number
- K240086 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Implantable cervical facet joint distractor FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Implantable cervical facet joint distractor
Disposable Impactor by Surgentec Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable cervical facet joint distractor.
- CAVUX™ Cervical Cage-L 10x12x15mm 7 deg — PROVIDENCE MEDICAL TECHNOLOGY, INC. · Class II
- CAVUX™ Cervical Cage-L 8x12x15mm 7 deg — PROVIDENCE MEDICAL TECHNOLOGY, INC. · Class II
- CORUS-LX Implant, 5mm — PROVIDENCE MEDICAL TECHNOLOGY, INC. · U
- CAVUX™ Cervical Cage-L 7x14x17mm — PROVIDENCE MEDICAL TECHNOLOGY, INC. · Class II
- CAVUX™ Cervical Cage-L 9x14x17mm — PROVIDENCE MEDICAL TECHNOLOGY, INC. · Class II
- CORUS-LX Implant, 4mm — PROVIDENCE MEDICAL TECHNOLOGY, INC. · U
- CORUS PCSS Implant, 5mm — PROVIDENCE MEDICAL TECHNOLOGY, INC.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K240086 also covers:
- Disposable 4.5mm Drill Bit — SURGENTEC LLC
- Disposable 5.0mm Drill Bit — SURGENTEC LLC
- Disposable 5.5mm Drill Bit — SURGENTEC LLC
- Disposable Circular Decortication Rasp — SURGENTEC LLC
- Disposable Graft Tamp — SURGENTEC LLC
- Disposable Impactor - No Guidewire — SURGENTEC LLC
- Disposable Instrument Removal Tool — SURGENTEC LLC
- ION Disposable Facet Screw Inserter AO — SURGENTEC LLC
- ION Disposable Plastic Drill Guide — SURGENTEC LLC
- ION Disposable XXXX — SURGENTEC LLC
- ION Disposable XXXX — SURGENTEC LLC
- ION Disposable XXXX — SURGENTEC LLC
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgentec Llc
Sources (1)
- FDA UDI 761b43c9-3126-4e19-8c3a-921aca5d355f 33 fields · synced May 30, 2026