FDA.report

HNM TOTAL RECON

Primary DI
00841742145013
Brand
HNM TOTAL RECON
Company
HNM TOTAL RECON LLC
Model
HTR-26-300-27
Catalog number
HTR-26-300-27
Device description
HBS Standard Compression Ø3.0mm - (L) 27mm
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K030302000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K030302000HBS HEADLESS BONE SCREWSchoening & Assoc., Inc.2003-08-08HWC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841742145013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841742145013008417421450138417421450130841742145013

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080024940
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00841742143910ORIONHTR-04-304440HTR-04-3044402020-11-18
00841742143927ORIONHTR-04-404514HTR-04-4045142020-11-18
00841742143934ORIONHTR-04-404616HTR-04-4046162020-11-18
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