FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLATEAU SPACER SYSTEM
K Number: K111835
·
Decision Jul 19, 2011
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
84
Review Days
20
Basic Information
- Device Name
- PLATEAU SPACER SYSTEM
- K Number
- K111835
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Spine, Inc.
- Date Received
- June 29, 2011
- Decision Date
- July 19, 2011
- Product Code
- ODP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODP), ordered by most recent decision date.
BluEX Cervical Expandable Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOMNI SPINAL CAGES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ORIO-3D Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MOD-C
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Life Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Jun 2, 2026 | Substantially Equivalent |
| K260837 | VersaLift Expandable System | May 12, 2026 | Substantially Equivalent |
| K254274 | ARx® SAI Implant System | Apr 16, 2026 | Substantially Equivalent |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Jan 23, 2026 | Substantially Equivalent |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Jul 7, 2025 | Substantially Equivalent |
| K250373 | ProLift Expandable Spacer System | Apr 9, 2025 | Substantially Equivalent |
| K243668 | ProLift Pivot Expandable Spacer System | Jan 23, 2025 | Substantially Equivalent |
| K243369 | Cervical Plating System | Dec 11, 2024 | Substantially Equivalent |
| K242826 | ProLift Wedge Expandable Spacer System | Oct 8, 2024 | Substantially Equivalent |
| K241464 | ARx® SAI Implant System | Jul 29, 2024 | Substantially Equivalent |