Flexlite Camera
510(k) K122134
Flexlite Camera is a Class II device made by Spine View, Inc., cleared under FDA 510(k) K122134 on 27 Dec 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122134 | Date27 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K122134
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code HRX (Arthroscope).
- ARTHROPLANE by SYNVASIVE TECHNOLOGY, INC.
- CONCEPT CURETTE by Concept, Inc.
- SHAVER ABLATOR by Linvatec Corp.
- ZIMMER ARTHROSCOPY SYSTEM by Zimmer, Inc.
- MEDINAUT Plus Kyphoplasty System PICD-BI1/ PICD-BIC1 by IMEDICOM CO., LTD.
- SMARTRELEASE Endoscopic Soft Tissue Release System by MicroAire Surgical Instruments LLC
- ACUFEX ENDOBUTTON PACK by Acufex Microsurgical, Inc.
- NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR by Surgical Dynamics, Inc.
- RIGID NEUROVIEW ENDOSCOPE by Neuro Navigational Corp.
- MEDINAUT-I(ICD System) MEDICOM-CD by IMEDICOM CO., LTD.