510(k) K993956 ยท HSB Rod, Fixation, Intramedullary And Accessories
TITANIUM PEDIATRIC FEMORAL NAIL
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 20, 1999 |
| Received | Nov 22, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993956
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2009 | EBI, L.P. Pediatric Femoral Nail 5.5MM (d) x 28 CM (L)
Rx only, Sterile;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment a Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Pediatric Femoral Nail 5.5MM (d) x 30 CM (L)
Rx only, Sterile;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment a Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Pediatric Femoral Nail 5.5MM (d) x 32 CM (L)
Rx only, Sterile;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054The screw devices are an internal fixation device intended to aid in the alignment an Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Pediatric Femoral Nail 5.5MM (d) x 36 CM (L)
Rx only, Sterile;
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment a Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw, 6.5mm (D) x 40mm (L),
Made in USA; Biomet Spine, Parsippany, NJ
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures t Terminated |
MNH | None listed |
| Sep 22, 2009 | EBI, L.P. Fixed Open Screw (TI);
7.0MM (D) x 30MM (L);
Made In USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fr Terminated |
MNH | None listed |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw (Ti);
5.0MM (D) x 25MM (L);
Made in USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of Terminated |
MNH | None listed |
| Sep 22, 2009 | EBI, L.P. Fixed Closed Screw (Ti);
6.0MM (D) x 40 MM (L)
Made In USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of Terminated |
MNI | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System
Made in USA, Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
MQP | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System;
Made in USA
Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
MQP | None listed |
| Sep 22, 2009 | EBI, L.P. Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar;
Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fract Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.