510(k) K971682
- Device
- J-FX CERCLAGE SYSTEM
- Applicant
- JOHNSON & JOHNSON PROFESSIONALS, INC.
- 510(k) number
- K971682
- Product code
- LRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-27
- Date received
- 1997-05-06
- Regulation
- 888.3030
- Classification name
- Wire, Surgical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN FERROS
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 1219655
- 3014725904
- 3008556682
- 3010173425
- 1030489
- 3004464325
- 2028632
- 3015516266
- 3013014058
- 3018094310
- 1526534
- 3008102042
- 1818910
- 3025141
- 2647346
- 3008812251
- 1720929
- 3006128100
- 1824199
- 3004748528
- 2249697
- 2029275
- 9616671
- 8043792
- 3015440604
- 9616680
- 3010362364
- 8010379
- 3003120897
- 2080222
- 8010177
- 8031010
- 9610726
- 3006017180
- 3006001176
- 1043653
- 3001278222
- 8044172
- 2032098
- 8031020
- 3006356043
Source Documents#
Other 510(k) Records For Product Code LRN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | T. Korossurgical Instruments Corp. | 2000-12-04 |
| K990355 | STAINLESS STEEL SOFT SUTURE WIRE | Bregma International Trading Company , Ltd. | 1999-07-08 |
| K952783 | OXBORO-MEDICAL PIN COVERS | Oxboro Medical Intl., Inc. | 1995-09-15 |
| K942603 | ORTHOPAEDIC WIRES | Acu Med, Inc. | 1994-11-09 |
| K900926 | TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) | Howmedica Corp. | 1990-04-23 |
| K892651 | SONGER WIRING SYSTEM | Danek Medical, Inc. | 1989-07-25 |
| K864375 | TYPE 316L COTTER WIRE | Winn Hirsch & Assoc. | 1987-05-20 |
Legacy Summary#
summary
FDA Review#
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