510(k) K873251 ยท HWC Screw, Fixation, Bone
OMNIFIT BONE SCREW
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Sep 18, 1987 |
| Received | Aug 17, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 16 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 20 mm; Sterile
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 25 mm; Sterile;
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 30 mm; Sterile;
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 40 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 45 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 50 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 60 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 15 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 20 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 25 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 30 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 35 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 40 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 5.5 mm; Lnth: 50 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Bone Screw;
Dia 6.5 mm; Lnth: 25 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that may be use Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Bone Screw;
Dia 6.5 mm; Lnth: 30 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that may be use Terminated |
HWC | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 15 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430. Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 20 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 25 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 30 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 35 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 40 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 45 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 50 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 55 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Gap Plate Screw;
Dia. 6.5 mm, Lnth 60 mm;
Made in USA, Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 Terminated |
MEH | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 35 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| Sep 22, 2008 | Stryker Howmedica Osteonics Corp. 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Numb Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.