510(k) K040363
- Device
- CERAMIC TIPPED SKULL PIN
- Applicant
- THE JEROME GROUP, INC.
- 510(k) number
- K040363
- Product code
- LYT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-04-12
- Date received
- 2004-02-13
- Regulation
- 888.3030
- Classification name
- Fixation Accessory
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD KOWALSKI
- Address
- 305 Harper Dr. Moorestown NJ US 08057 08057
FDA Registration Numbers#
- 9616680
- 3013014058
- 2183463
- 2249697
- 9610726
- 3010173425
- 3008556682
Source Documents#
Other 510(k) Records For Product Code LYT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983685 | BONE BAND | Chapel and Assoc. | 1998-12-04 |
| K980594 | OSTEONICS FX-CABLELOK GRIP COMPONENTS | Osteonics Corp. | 1998-05-05 |
| K914812 | K-CAP-E, STERILE | Westcon Orthopedics, Inc. | 1992-01-09 |
| K912762 | K-CAP-I, STERILE | Westcon Orthopedics, Inc. | 1991-07-18 |
| K902053 | K-CAP-I ORTHOPEDIC FIXATION WIRE CAP | Westcon Orthopedics, Inc. | 1990-09-14 |
| K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | Micro-Aire Surgical Instruments, Inc. | 1990-09-14 |
| K883576 | HORIZON ORTHOPEDIC PIN PROTECTOR | Horizon Medical, Inc. | 1988-09-30 |
| K831072 | JURGAN PIN BALL | Jurgan Development & Mfg., Ltd. | 1983-06-08 |
Legacy Summary#
summary
FDA Review#
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