FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
GDLH VARIABLE ANGLE CONNECTOR
K Number: K934582
·
Decision Jun 21, 1994
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
2
Review Days
271
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
- GDLH VARIABLE ANGLE CONNECTOR
- K Number
- K934582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Danek Group, Inc.
- Date Received
- September 23, 1993
- Decision Date
- June 21, 1994
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWP), ordered by most recent decision date.
LnK Posterior Cervical Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
OASYS System
FDA 510(k)
FDA Class 2
·Orthopedic
Sure Lok Mini Posterior Cervical/Upper Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
Reliance Posterior Cervical-Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
Streamline OCT Occipito-Cervico-Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
SOLSTICE OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Danek Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K936307 | DYNA-LOK ANTERIOR PLATING SYSTEM | Aug 14, 1995 | Substantially Equivalent for Some Indications |