FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
K Number: K060097
·
Decision Feb 27, 2006
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
42
Applicant Total
58
Review Days
45
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
- K Number
- K060097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KLS-Martin L.P.
- Date Received
- January 13, 2006
- Decision Date
- February 27, 2006
- Product Code
- GZT
- 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 |
|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZT), ordered by most recent decision date.
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
FDA 510(k)
FDA Class 2
·Neurology
Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family)
FDA 510(k)
FDA Class 2
·Neurology
MindsEye Expandable Port
FDA 510(k)
FDA Class 2
·Neurology
Geister retractor for neuro - and spine surgery
FDA 510(k)
FDA Class 2
·Neurology
NICO BrainPath
FDA 510(k)
FDA Class 2
·Neurology
MEDICON Spinal Spreading Systems
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by KLS-Martin L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K253660 | KLS Martin Pure Pectus System | Feb 20, 2026 | Substantially Equivalent |
| K250988 | KLS Martin Pure Pectus System | Dec 11, 2025 | Substantially Equivalent |
| K250865 | KLS Martin IPS Forearm System | Nov 14, 2025 | Substantially Equivalent |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | Nov 10, 2025 | Substantially Equivalent |
| K233721 | KLS Martin Drill-Free MMF Screw | Sep 17, 2024 | Substantially Equivalent |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | Aug 16, 2024 | Substantially Equivalent |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | Jul 12, 2024 | Substantially Equivalent |
| K230211 | CranioXpand | Nov 21, 2023 | Substantially Equivalent |
| K222624 | KLS Martin LINOS Wrist System | May 25, 2023 | Substantially Equivalent |
| K222397 | KLS Martin Level One Rib Fixation System | Mar 29, 2023 | Substantially Equivalent |