FDA.report

Hintermann Distractor

Primary DI
M209232590
Brand
Hintermann Distractor
Company
BIOPRO, INC.
Model
23259
Published
2026-05-22
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GADRetractor

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M209232590PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
618749857
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company

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M209232580Hintermann Compressor232582026-05-22
M20923217MTP Targeting Guide Assembly232172025-11-28
M20923227Modular Thumb Rasp Serrated 7.5MM232272025-11-28
M20923228Modular Thumb Rasp Serrated 8.5MM232282025-11-28
M20923229Modular Thumb Rasp Serrated 10.0MM232292025-11-28
M20923230Modular Thumb Rasp Serrated 11.5MM232302025-11-28
M209177990THUMB MOD HEAD TITANIUM 13MM+2177992024-06-30
M209178000THUMB MOD HEAD TITANIIUM 12MM177802024-06-30
M209178010THUMB MOD HEAD TITANIUM 12MM+2178012024-06-30
M209178060THUMB MOD HEAD TITANIUM 14MM178062024-06-30
M209178070THUMB MOD HEAD TITANIUM 14MM+2178072024-06-30
M209178080THUMB MOD HEAD TITANIUM 15MM178082024-06-30
M209178090THUMB MOD HEAD TITANIUM 15MM+2178092024-06-30
M209177980THUMB MOD HEAD TITANIUM 13MM177982024-05-30
M209230790MTP FUSION PLATE 5 DEGREE, LEFT230792024-03-26
M209230800MTP FUSION PLATE 5 DEGREE, RIGHT230802024-03-26
M209230810MTP FUSION PLATE 0 DEGREE, LEFT230812024-03-26
M209230820MTP FUSION PLATE 0 DEGREE, RIGHT230822024-03-26
M209230830MTP FUSION PLATE, NARROW 10 DEGREE, LEFT230832024-03-26
M20923084MTP FUSION PLATE, NARROW 10 DEGREE, RIGHT230842024-03-26

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