FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K Number: K033341
·
Decision Sep 10, 2004
Classifications
1
FEI Numbers
246
Registration Numbers
246
Same Product Code
417
Applicant Total
423
Review Days
329
Basic Information
- Device Name
- SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
- K Number
- K033341
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SMITH & NEPHEW, INC.
- Date Received
- October 17, 2003
- Decision Date
- September 10, 2004
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAW), ordered by most recent decision date.
EZ-FIDUCIALS
FDA 510(k)
FDA Class 2
·Neurology
Stereotaxic Guiding Surgical Devices, NaoTrac S
FDA 510(k)
FDA Class 2
·Neurology
Navient Image Guide Navigation System (955-NC-NC), Cranial
FDA 510(k)
FDA Class 2
·Neurology
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
FDA 510(k)
FDA Class 2
·Neurology
ClearPoint System (Software Version 3.0)
FDA 510(k)
FDA Class 2
·Neurology
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by SMITH & NEPHEW, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | Jun 8, 2017 | Substantially Equivalent |
| K163086 | VLP MINI-MOD 2.0mm Column Plates | Dec 21, 2016 | Substantially Equivalent |
| K161233 | OXINIUM DH Fermoral Heads | Dec 14, 2016 | Substantially Equivalent |
| K161264 | TRIGEN Low Profile Bone Screws | Nov 23, 2016 | Substantially Equivalent |
| K162078 | EVOS Small Fragment Plating System | Nov 18, 2016 | Substantially Equivalent |
| K160923 | REDAPT Anteverted Cemented Liner | Nov 17, 2016 | Substantially Equivalent |
| K161665 | VLP Wrist Fracture System | Nov 15, 2016 | Substantially Equivalent |
| K152163 | RENASYS GO | Sep 29, 2016 | Substantially Equivalent |
| K160738 | ZUK Select Knee System | Jun 15, 2016 | Substantially Equivalent |
| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | Dec 2, 2015 | Substantially Equivalent |