Implant, Fixation Device, Spinal
A spinal fixation implant is an orthopedic device surgically implanted in the spine to provide structural stabilization, typically consisting of rods, screws, hooks, or wires that immobilize vertebral segments following spinal fusion procedures or to correct deformity and instability. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDN, regulated under 21 CFR 888.3060, within the Orthopedic medical specialty. This device is an implant.
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Basic Information
- Product Code
- JDN
- Device Class
- FDA class 2
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K954856 | CANNULATED FEMORAL NAIL | Mar 08, 1996 | Substantially Equivalent | Synthes (Usa) |
| K897141 | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | Jun 21, 1990 | Substantially Equivalent for Some Indications | Stuart |
| K894184 | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM | Apr 25, 1990 | Substantially Equivalent for Some Indications | Biedermann Motech GmbH |
| K873977 | NEW C-D SYSTEM FOR SPINAL SURGERY | Dec 07, 1987 | Substantially Equivalent for Some Indications | Sofamor Co. |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Dec 07, 1987 | Substantially Equivalent for Some Indications | Roseburg SA |
| K760649 | TOTAL SPINAL CORRECTION | Oct 05, 1976 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.