Atlas FDA

OMNIFIT BONE SCREW

FDA 510(k) clearance K873251 · decided 1987-09-18

Clearance details

K-number
K873251
Device name
OMNIFIT BONE SCREW
Applicant
Osteonics Corp.
Decision
Substantially Equivalent for Some Indications
Date received
1987-08-17
Decision date
1987-09-18
Days to decision
32 days
Clearance type
Traditional
Product code
HWC
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 16 mm; Sterile: Made in the recall (Z-2117-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 20 mm; Sterile Made in the U recall (Z-2118-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 25 mm; Sterile; Made in the recall (Z-2119-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 30 mm; Sterile; Made in the recall (Z-2120-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 40 mm; Sterile: Made in the recall (Z-2121-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 45 mm; Sterile: Made in the recall (Z-2122-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 50 mm; Sterile: Made in the recall (Z-2123-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 60 mm; Sterile: Made in the recall (Z-2124-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 15 mm; Sterile: Made in the recall (Z-2125-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 20 mm; Sterile: Made in the recall (Z-2126-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 25 mm; Sterile: Made in the recall (Z-2127-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 30 mm; Sterile: Made in the recall (Z-2128-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 35 mm; Sterile: Made in the recall (Z-2129-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 40 mm; Sterile: Made in the recall (Z-2130-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 50 mm; Sterile: Made in the recall (Z-2131-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Bone Screw; Dia 6.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryke recall (Z-2132-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Bone Screw; Dia 6.5 mm; Lnth: 30 mm; Sterile: Made in the USA; Stryke recall (Z-2133-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 15 mm; Made in USA, St recall (Z-2134-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 20 mm; Made in USA, St recall (Z-2135-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 25 mm; Made in USA, St recall (Z-2136-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 30 mm; Made in USA, St recall (Z-2137-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, St recall (Z-2138-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 40 mm; Made in USA, St recall (Z-2139-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 45 mm; Made in USA, St recall (Z-2140-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 50 mm; Made in USA, St recall (Z-2141-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 55 mm; Made in USA, St recall (Z-2142-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 60 mm; Made in USA, St recall (Z-2143-2009)Stryker Howmedica Osteonics Corp.2009-09-14
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 35 mm; Sterile: Made in the recall (Z-2176-2009)Stryker Howmedica Osteonics Corp.2009-09-14
6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteon recall (Z-2007-2008)Stryker Howmedica Osteonics Corp.2008-09-22