Fixation Accessory
The Fixation Accessory (product code LYT) is an orthopedic implant component used as a supplemental element within internal fixation systems to stabilize fractures or support bone reconstruction, such as washers, screws, or plates used in conjunction with primary fixation hardware. Regulated under 21 CFR 888.3030 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant. The device falls under the Orthopedic specialty. It is not life-sustaining.
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Basic Information
- Product Code
- LYT
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040363 | CERAMIC TIPPED SKULL PIN | Apr 12, 2004 | Substantially Equivalent | The Jerome Group, Inc. |
| K983685 | BONE BAND | Dec 04, 1998 | Substantially Equivalent | Chapel and Assoc. |
| K980594 | OSTEONICS FX-CABLELOK GRIP COMPONENTS | May 05, 1998 | Substantially Equivalent | Osteonics Corp. |
| K914812 | K-CAP-E, STERILE | Jan 09, 1992 | Substantially Equivalent | Westcon Orthopedics, Inc. |
| K912762 | K-CAP-I, STERILE | Jul 18, 1991 | Substantially Equivalent | Westcon Orthopedics, Inc. |
| K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | Sep 14, 1990 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K902053 | K-CAP-I ORTHOPEDIC FIXATION WIRE CAP | Sep 14, 1990 | Substantially Equivalent | Westcon Orthopedics, Inc. |
| K883576 | HORIZON ORTHOPEDIC PIN PROTECTOR | Sep 30, 1988 | Substantially Equivalent | Horizon Medical, Inc. |
| K831072 | JURGAN PIN BALL | Jun 08, 1983 | Substantially Equivalent | Jurgan Development & Mfg., Ltd. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.