FDA.report

CHS

Primary DI
03596010457585
Brand
CHS
Company
Smith & Nephew, Inc.
Model
71161354
Catalog number
71161354
Device description
TITANIUM CLASSIC PLATE 4 HOLE 135 DEGREE
Published
2015-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K952697000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K952697000TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEMSmith & Nephew Richards, Inc.1995-09-12HWC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010457585PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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